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Janssen-Cilag International NV

Check drug filings and source records for this company-name string.

Listed by the company name as recorded in the source, without merging affiliated entities.

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Complete CDE snapshot
2026/11/11 06:42
Matching scope
Loaded public-source records only

These counts cover loaded acceptance records only. First-applicant and co-applicant counts are not added together. CDE data as of 2026/11/11 06:42.

Drug filings

325 acceptance records as first applicant, grouped into 40 source drug names. Source data as of 2026/11/11 06:42.

Acceptance records are de-duplicated by acceptance number. Drug names are normalized only for width and whitespace; dosage forms and combinations remain separate. Application types are retained from the source. Expand a drug to inspect each record. Published drugs link to their drug pages; other names do not create new public drug pages.

No verified English name 27 records · Latest accepted 2026/11/05

Supplement · 25Import re-registration · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYSB2600311Supplement2026/11/05Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2600310Supplement2026/11/05Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2600261Supplement2026/09/22Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2500196Supplement2025/08/23Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2500195Supplement2025/08/23Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2500194Supplement2025/08/23Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2500127Supplement2025/05/31Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2500126Supplement2025/05/31Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2500125Supplement2025/05/31Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2500093Supplement2025/04/03Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2500092Supplement2025/04/03Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2400229Supplement2024/10/17Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2400228Supplement2024/10/17Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2300220Supplement2023/12/20Janssen-Cilag International NV; Cilag AGCDE ↗
JYSZ2300031Import re-registration2023/07/25Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYSZ2300030Import re-registration2023/07/25Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYSB2300044Supplement2023/03/07Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2300043Supplement2023/03/07Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2200172Supplement2022/09/04Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2200132Supplement2022/07/20Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2200131Supplement2022/07/20Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2200102Supplement2022/06/20Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2200101Supplement2022/06/20Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2200098Supplement2022/06/16Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2200097Supplement2022/06/16Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2101093Supplement2021/07/27Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2101092Supplement2021/07/27Janssen-Cilag International NV; Cilag AGCDE ↗
No verified English name 2 records · Latest accepted 2026/10/23

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYSB2600292Supplement2026/10/23Janssen-Cilag International NV; Cilag AG; Patheon Italia S.p.A.CDE ↗
JYSB2600140Supplement2026/06/04Janssen-Cilag International NV; Cilag AGCDE ↗
Ibrutinib Capsules 13 records · Latest accepted 2026/10/21

Supplement · 10Import re-registration · 2Import · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2600561Supplement2026/10/21Janssen-Cilag International NV; Catalent CTS LLC; Cilag AGCDE ↗
JYHZ2600188Import re-registration2026/08/05Janssen-Cilag International NV; Catalent CTS LLC; Cilag AG; Xian-Janssen Pharmaceutical Ltd.CDE ↗
JYHB2600055Supplement2026/01/23Janssen-Cilag International NV; Catalent CTS LLCCDE ↗
JYHB2400638Supplement2024/12/12Janssen-Cilag International NV; Catalent CTS LLCCDE ↗
JYHB2400574Supplement2024/10/28Janssen-Cilag International NV; Catalent CTS LLCCDE ↗
JYHB2400150Supplement2024/04/08Janssen-Cilag International NV; Catalent CTS LLC; Cilag AGCDE ↗
JYHB2200549Supplement2022/10/12Janssen-Cilag International NV; Catalent CTS LLCCDE ↗
JYHB2200458Supplement2022/08/19Janssen-Cilag International NV; Catalent CTS LLCCDE ↗
JXHS2200052Import2022/05/31Janssen-Cilag International NV; Catalent CTS LLC; Xian-Janssen Pharmaceutical Ltd.CDE ↗
JYHB2200236Supplement2022/04/24Janssen-Cilag International NV; Catalent CTS LLCCDE ↗
JYHB2101476Supplement2021/10/21Janssen-Cilag International NV; Catalent CTS LLCCDE ↗
JYHZ2100646Import re-registration2021/10/09Janssen-Cilag International NV; Catalent CTS LLC; Xian-Janssen Pharmaceutical Ltd.CDE ↗
JYHB2100105Supplement2021/02/02Janssen-Cilag International NV; Catalent CTS LLCCDE ↗
Canagliflozin Tablets 16 records · Latest accepted 2026/10/21

Supplement · 14Import re-registration · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2600564Supplement2026/10/21Janssen-Cilag International NV; Janssen-Cilag S.p.A.CDE ↗
JYHB2600563Supplement2026/10/21Janssen-Cilag International NV; Janssen-Cilag S.p.A.CDE ↗
JYHB2500363Supplement2025/07/10Janssen-Cilag International NV; Janssen-Cilag S.p.A.CDE ↗
JYHB2500362Supplement2025/07/10Janssen-Cilag International NV; Janssen-Cilag S.p.A.CDE ↗
JYHB2400616Supplement2024/11/28Janssen-Cilag International NV; Janssen-Cilag S.p.A.CDE ↗
JYHB2400615Supplement2024/11/28Janssen-Cilag International NV; Janssen-Cilag S.p.A.CDE ↗
JYHZ2400275Import re-registration2024/10/12Janssen-Cilag International NV; Janssen-Cilag S.p.A.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHZ2400274Import re-registration2024/10/12Janssen-Cilag International NV; Janssen-Cilag S.p.A.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHB2300622Supplement2023/11/01Janssen-Cilag International NV; Janssen-Cilag S.p.A.CDE ↗
JYHB2300621Supplement2023/11/01Janssen-Cilag International NV; Janssen-Cilag S.p.A.CDE ↗
JYHB2300185Supplement2023/03/21Janssen-Cilag International NV; Janssen-Cilag S.p.A.CDE ↗
JYHB2300184Supplement2023/03/21Janssen-Cilag International NV; Janssen-Cilag S.p.A.CDE ↗
JYHB2200296Supplement2022/06/14Janssen-Cilag International NV; Janssen-Cilag S.p.A.CDE ↗
JYHB2200295Supplement2022/06/14Janssen-Cilag International NV; Janssen-Cilag S.p.A.CDE ↗
JYHB2101050Supplement2021/04/16Janssen-Cilag International NV; Janssen-Cilag S.p.A.CDE ↗
JYHB2101049Supplement2021/04/16Janssen-Cilag International NV; Janssen-Cilag S.p.A.CDE ↗
No verified English name 6 records · Latest accepted 2026/10/19

Import · 4Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JXSS2600097Import2026/10/19Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JXSS2600096Import2026/10/19Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JYSB2500136Supplement2025/06/17Janssen-Cilag International NV; Patheon Manufacturing Services LLCCDE ↗
JYSB2500135Supplement2025/06/17Janssen-Cilag International NV; Patheon Manufacturing Services LLCCDE ↗
JXSS2400012Import2024/02/08Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JXSS2400011Import2024/02/08Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
Bortezomib For Injection 3 records · Latest accepted 2026/10/16

Import re-registration · 1Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2600266Import re-registration2026/10/16Janssen-Cilag International NV; BSP Pharmaceuticals S.p.A.; XIAN JANSSEN PHARMACEUTICAL Ltd.CDE ↗
JYHB2400468Supplement2024/08/30Janssen-Cilag International NV; BSP Pharmaceuticals S.p.A.CDE ↗
JYHB2400033Supplement2024/01/23Janssen-Cilag International NV; BSP Pharmaceuticals S.p.A.CDE ↗
Apalutamide Tablets 13 records · Latest accepted 2026/09/22

Supplement · 11Import · 1Import re-registration · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2600530Supplement2026/09/22Janssen-Cilag International NV; Janssen Ortho LLC; Catalent Pharma Solutions LLCCDE ↗
JXHS2600061Import2026/06/10Janssen-Cilag International NV; Janssen Ortho LLC; Catalent Pharma Solutions LLC; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHB2500062Supplement2025/02/08Janssen-Cilag International NV; Janssen Ortho LLC; Catalent Pharma Solutions LLCCDE ↗
JYHB2400544Supplement2024/10/13Janssen-Cilag International NV; Janssen Ortho LLC; Catalent Pharma Solutions LLCCDE ↗
JYHB2400175Supplement2024/04/23Janssen-Cilag International NV; Janssen Ortho LLCCDE ↗
JYHZ2400051Import re-registration2024/02/28Janssen-Cilag International NV; Janssen Ortho LLC; Xian-Janssen Pharmaceutical Ltd.CDE ↗
JYHB2300745Supplement2023/12/26Janssen-Cilag International NV; Janssen Ortho LLCCDE ↗
JYHB2300569Supplement2023/10/11Janssen-Cilag International NV; 1. Catalent Pharma Solutions LLC; 2. Janssen Ortho LLCCDE ↗
JYHB2300568Supplement2023/10/10Janssen-Cilag International NV; Janssen Ortho LLCCDE ↗
JYHB2300128Supplement2023/02/17Janssen-Cilag International NV; Janssen Ortho LLCCDE ↗
JYHB2300075Supplement2023/01/31Janssen-Cilag International NV; Janssen Ortho LLCCDE ↗
JYHB2200003Supplement2022/01/06Janssen-Cilag International NV; Janssen Ortho LLCCDE ↗
JYHB2100139Supplement2021/02/11Janssen-Cilag International NV; Janssen Ortho LLCCDE ↗
Selexipag Tablets 18 records · Latest accepted 2026/09/20

Import · 10Supplement · 8

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JXHS2600113Import2026/09/20Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JXHS2600112Import2026/09/20Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JXHS2600111Import2026/09/20Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JXHS2600110Import2026/09/20Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JXHS2600109Import2026/09/20Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JXHS2600108Import2026/09/20Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JXHS2600107Import2026/09/20Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JXHS2600106Import2026/09/20Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JXHS2600092Import2026/08/17Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JXHS2600091Import2026/08/17Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JYHB2600013Supplement2026/01/05Janssen-Cilag International NV; Excella GmbH & Co. KGCDE ↗
JYHB2600012Supplement2026/01/05Janssen-Cilag International NV; Excella GmbH & Co. KGCDE ↗
JYHB2600011Supplement2026/01/05Janssen-Cilag International NV; Excella GmbH & Co. KGCDE ↗
JYHB2600010Supplement2026/01/05Janssen-Cilag International NV; Excella GmbH & Co. KGCDE ↗
JYHB2600009Supplement2026/01/05Janssen-Cilag International NV; Excella GmbH & Co. KGCDE ↗
JYHB2600008Supplement2026/01/05Janssen-Cilag International NV; Excella GmbH & Co. KGCDE ↗
JYHB2600007Supplement2026/01/05Janssen-Cilag International NV; Excella GmbH & Co. KGCDE ↗
JYHB2600006Supplement2026/01/05Janssen-Cilag International NV; Excella GmbH & Co. KGCDE ↗
No verified English name 28 records · Latest accepted 2026/06/25

Supplement · 16Import · 10Import re-registration · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYSB2600184Supplement2026/06/25Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2600183Supplement2026/06/25Janssen-Cilag International NV; Cilag AGCDE ↗
JXSS2600037Import2026/04/16Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
JXSS2600036Import2026/04/16Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
JXSL2500206Import2025/10/18Janssen-Cilag International NV; Johnson & Johnson (China) Investment Ltd.CDE ↗
JXSS2500022Import2025/03/06Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
JXSS2400104Import2024/11/27Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYSB2400221Supplement2024/10/10Janssen-Cilag International NV; Cilag AGCDE ↗
JXSS2400053Import2024/07/03Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
JXSS2400052Import2024/07/03Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYSZ2400022Import re-registration2024/05/06Janssen-Cilag International NV; Cilag AG; XIAN JANSSEN PHARMACEUTICAL LTD.CDE ↗
JYSZ2400021Import re-registration2024/05/06Janssen-Cilag International NV; Cilag AG; XIAN JANSSEN PHARMACEUTICAL LTD.CDE ↗
JYSB2400085Supplement2024/04/20Janssen-Cilag International NV; Cilag AGCDE ↗
JXSS2400028Import2024/03/27Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
JXSS2400027Import2024/03/27Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYSB2300014Supplement2023/01/31Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2300013Supplement2023/01/31Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2300011Supplement2023/01/17Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2300010Supplement2023/01/17Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2200211Supplement2022/11/15Janssen-Cilag International NV; Cilag AGCDE ↗
JXSL2200163Import2022/09/09Janssen-Cilag International NV; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYSB2101189Supplement2021/12/09Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2101188Supplement2021/12/09Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2101133Supplement2021/09/13Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2101024Supplement2021/05/14Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2100074Supplement2021/03/12Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2100003Supplement2021/01/07Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2100002Supplement2021/01/07Janssen-Cilag International NV; Cilag AGCDE ↗
No verified English name 10 records · Latest accepted 2026/06/24

Supplement · 6Import · 4

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYSB2600182Supplement2026/06/24Janssen-Cilag International NV; Patheon Manufacturing Services LLCCDE ↗
JYSB2600181Supplement2026/06/24Janssen-Cilag International NV; Patheon Manufacturing Services LLCCDE ↗
JXSS2600039Import2026/04/17Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JXSS2600038Import2026/04/17Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JYSB2500220Supplement2025/09/16Janssen-Cilag International NV; Patheon Manufacturing Services LLCCDE ↗
JYSB2500219Supplement2025/09/16Janssen-Cilag International NV; Patheon Manufacturing Services LLCCDE ↗
JYSB2400210Supplement2024/09/25Janssen-Cilag International NV; Patheon Manufacturing Services LLCCDE ↗
JYSB2400209Supplement2024/09/25Janssen-Cilag International NV; Patheon Manufacturing Services LLCCDE ↗
JXSS2300070Import2023/08/19Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JXSS2300069Import2023/08/19Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
No verified English name 3 records · Latest accepted 2026/06/23

Supplement · 1Import · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYSB2600174Supplement2026/06/23Janssen-Cilag International NV; Cilag AGCDE ↗
JXSS2400054Import2024/07/03Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
JXSS2400029Import2024/03/27Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
No verified English name 4 records · Latest accepted 2026/06/10

Supplement · 2Import · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2600317Supplement2026/06/10Janssen-Cilag International NV; Janssen-Cilag S.p.A.CDE ↗
JYHB2500458Supplement2025/08/27Janssen-Cilag International NV; Janssen-Cilag S.p.A.CDE ↗
JXHS2400076Import2024/10/11Janssen-Cilag International NV; JANSSEN CILAG S.P.A.; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JXHS2400009Import2024/01/26Janssen-Cilag International NV; JANSSEN CILAG S.P.A.; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
Miglustat Capsules 6 records · Latest accepted 2026/06/08

Import re-registration · 2Supplement · 4

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2600139Import re-registration2026/06/08Janssen-Cilag International NV; Almac Pharma Services Limited; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JYHB2400011Supplement2024/01/10Janssen-Cilag International NV; Almac Pharma Services LimitedCDE ↗
JYHB2300270Supplement2023/04/26Janssen-Cilag International NV; Almac Pharma Services LimitedCDE ↗
JYHB2200173Supplement2022/04/01Janssen-Cilag International NV; Almac Pharma Services LimitedCDE ↗
JYHZ2100534Import re-registration2021/04/30Janssen-Cilag International NV; Almac Pharma Services Limited; Actelion Pharmaceuticals Trading (Shanghai) Co. Ltd.CDE ↗
JYHB2100062Supplement2021/01/16Janssen-Cilag International NV; Almac Pharma Services LimitedCDE ↗
No verified English name 4 records · Latest accepted 2026/06/01

Import · 4

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JXSS2600045Import2026/06/01Janssen-Cilag International NV; Vetter Pharma-Fertigung GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JXSS2600044Import2026/06/01Janssen-Cilag International NV; Vetter Pharma-Fertigung GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JXSS2500050Import2025/04/23Janssen-Cilag International NV; Vetter Pharma-Fertigung GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JXSS2500049Import2025/04/23Janssen-Cilag International NV; Vetter Pharma-Fertigung GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
No verified English name 12 records · Latest accepted 2026/05/14

Supplement · 4Import · 8

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYSB2600125Supplement2026/05/14Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2600124Supplement2026/05/14Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2600123Supplement2026/05/14Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2600122Supplement2026/05/14Janssen-Cilag International NV; Cilag AGCDE ↗
JXSS2600013Import2026/03/01Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
JXSS2600012Import2026/03/01Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
JXSS2400085Import2024/10/11Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
JXSS2400084Import2024/10/11Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
JXSS2400078Import2024/09/25Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
JXSS2400077Import2024/09/25Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
JXSS2400076Import2024/09/25Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
JXSS2400075Import2024/09/25Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
No verified English name 2 records · Latest accepted 2026/05/08

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYSB2600110Supplement2026/05/08Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2600109Supplement2026/05/08Janssen-Cilag International NV; Cilag AGCDE ↗
Abiraterone Acetate Tablets 4 records · Latest accepted 2026/05/07

Supplement · 2Import re-registration · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2600244Supplement2026/05/07Janssen-Cilag International NV; Patheon Inc.CDE ↗
JYHZ2400132Import re-registration2024/05/23Janssen-Cilag International NV; Patheon Inc.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHZ2400131Import re-registration2024/05/23Janssen-Cilag International NV; Patheon Inc.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHB2101230Supplement2021/07/02Janssen-Cilag International NV; Patheon Inc.CDE ↗
No verified English name 13 records · Latest accepted 2026/04/23

Supplement · 9Import re-registration · 1Import · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYSB2600101Supplement2026/04/23Janssen-Cilag International NV; Cilag AGCDE ↗
JYSZ2600008Import re-registration2026/02/27Janssen-Cilag International NV; Cilag AG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JYSB2500172Supplement2025/07/24Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2500166Supplement2025/07/10Janssen-Cilag International NV; Cilag AGCDE ↗
JXSS2500061Import2025/05/14Janssen-Cilag International NV; Cilag AG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JYSB2500075Supplement2025/03/22Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2500022Supplement2025/02/07Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2300204Supplement2023/12/08Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2300140Supplement2023/08/18Janssen-Cilag International NV; Cilag AGCDE ↗
JXSL2300040Import2023/02/23Janssen-Cilag International NV; Johnson &Johnson(China)Investment Ltd.CDE ↗
JXSS2200013Import2022/04/15Janssen-Cilag International NV; Cilag AG; Xian-Janssen Pharmaceutical Ltd.CDE ↗
JYSB2200040Supplement2022/03/10Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2200015Supplement2022/01/30Janssen-Cilag International NV; Cilag AGCDE ↗
Paliperidone Extend-release Tablets 27 records · Latest accepted 2026/04/18

Import re-registration · 9Supplement · 18

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2600098Import re-registration2026/04/18Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHZ2600097Import re-registration2026/04/18Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHZ2600096Import re-registration2026/04/18Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHB2500249Supplement2025/05/01Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.CDE ↗
JYHB2500248Supplement2025/05/01Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.CDE ↗
JYHB2500247Supplement2025/05/01Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.CDE ↗
JYHB2300620Supplement2023/11/01Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.CDE ↗
JYHB2300619Supplement2023/11/01Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.CDE ↗
JYHB2300618Supplement2023/11/01Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.CDE ↗
JYHB2101590Supplement2021/12/14Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHB2101589Supplement2021/12/14Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHB2101588Supplement2021/12/14Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHB2101587Supplement2021/12/14Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHB2101586Supplement2021/12/14Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHB2101585Supplement2021/12/14Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHZ2100550Import re-registration2021/05/26Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHZ2100549Import re-registration2021/05/26Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHZ2100548Import re-registration2021/05/26Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHZ2100547Import re-registration2021/05/26Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHZ2100546Import re-registration2021/05/26Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHZ2100545Import re-registration2021/05/26Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHB2101019Supplement2021/04/01Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.CDE ↗
JYHB2101018Supplement2021/04/01Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.CDE ↗
JYHB2101017Supplement2021/04/01Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.CDE ↗
JYHB2101016Supplement2021/04/01Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.CDE ↗
JYHB2101015Supplement2021/04/01Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.CDE ↗
JYHB2101014Supplement2021/04/01Janssen-Cilag International NV; Janssen Cilag Manufacturing L.L.C.CDE ↗
Bedaquiline Fumarate Tablets 6 records · Latest accepted 2026/02/25

Import re-registration · 2Supplement · 4

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2600045Import re-registration2026/02/25Janssen-Cilag International NV; Recipharm Pharmaservices Private Limited; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHB2400511Supplement2024/09/28Janssen-Cilag International NV; Recipharm Pharmaservices Private LimitedCDE ↗
JYHB2400028Supplement2024/01/19Janssen-Cilag International NV; Recipharm Pharmaservices Private LimitedCDE ↗
JYHB2200608Supplement2022/11/08Janssen-Cilag International NV; Recipharm Pharmaservices Private LimitedCDE ↗
JYHB2200508Supplement2022/09/15Janssen-Cilag International NV; Recipharm Pharmaservices Private LimitedCDE ↗
JYHZ2100552Import re-registration2021/06/07Janssen-Cilag International NV; Recipharm Pharmaservices Private Limited; XIAN-JANSSEN PHARMACEUTICAL Ltd.CDE ↗
Paliperidone Palmitate Injection 21 records · Latest accepted 2026/02/13

Import re-registration · 6Supplement · 15

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2600042Import re-registration2026/02/13Janssen-Cilag International NV; Janssen Pharmaceutica N.V.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHZ2600041Import re-registration2026/02/13Janssen-Cilag International NV; Janssen Pharmaceutica N.V.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHZ2600040Import re-registration2026/02/13Janssen-Cilag International NV; Janssen Pharmaceutica N.V.; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHB2500682Supplement2025/12/10Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2500681Supplement2025/12/10Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2500680Supplement2025/12/10Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2500070Supplement2025/02/18Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2500069Supplement2025/02/18Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2500068Supplement2025/02/18Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2400478Supplement2024/09/04Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2400477Supplement2024/09/04Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2400476Supplement2024/09/04Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2300557Supplement2023/09/23Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2300556Supplement2023/09/23Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2300555Supplement2023/09/23Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHZ2100533Import re-registration2021/04/28Janssen-Cilag International NV; Janssen Pharmaceutica N.V.; Xian-Janssen Pharmaceutical Ltd.CDE ↗
JYHZ2100532Import re-registration2021/04/28Janssen-Cilag International NV; Janssen Pharmaceutica N.V.; Xian-Janssen Pharmaceutical Ltd.CDE ↗
JYHZ2100531Import re-registration2021/04/28Janssen-Cilag International NV; Janssen Pharmaceutica N.V.; Xian-Janssen Pharmaceutical Ltd.CDE ↗
JYHB2101047Supplement2021/04/15Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2101046Supplement2021/04/15Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2101045Supplement2021/04/15Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
Macitentan Tablets 1 records · Latest accepted 2026/01/31

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2600075Supplement2026/01/31Janssen-Cilag International NV; Excella GmbH & Co.KGCDE ↗
No verified English name 8 records · Latest accepted 2026/01/30

Import · 2Supplement · 6

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JXHL2600030Import2026/01/30Janssen-Cilag International NV; Johnson & Johnson (China) Investment Ltd.?CDE ↗
JYHB2500675Supplement2025/12/10Janssen-Cilag International NV; Renaissance Lakewood LLCCDE ↗
JYHB2500192Supplement2025/04/03Janssen-Cilag International NV; Renaissance Lakewood LLC; Janssen Cilag Manufacturing LLCCDE ↗
JYHB2500175Supplement2025/03/21Janssen-Cilag International NV; Renaissance Lakewood LLCCDE ↗
JYHB2400519Supplement2024/10/09Janssen-Cilag International NV; Renaissance Lakewood LLCCDE ↗
JYHB2400118Supplement2024/03/09Janssen-Cilag International NV; Renaissance Lakewood LLCCDE ↗
JYHB2300611Supplement2023/10/26Janssen-Cilag International NV; Renaissance Lakewood LLCCDE ↗
JXHS2200017Import2022/01/27Janssen-Cilag International NV; Renaissance Lakewood LLC; XIAN JANSSEN PHARMACEUTICAL LTD.CDE ↗
No verified English name 1 records · Latest accepted 2025/11/19

Import · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JXHS2500133Import2025/11/19Janssen-Cilag International NV; JANSSEN CILAG S.P.A.; Xian Janssen Pharmaceutical Ltd.CDE ↗
Decitabine For Injection 3 records · Latest accepted 2025/09/19

Import re-registration · 1Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2500208Import re-registration2025/09/19Janssen-Cilag International NV; BSP Pharmaceuticals S. p. A.; Xian-Janssen Pharmaceutical Ltd.CDE ↗
JYHB2200127Supplement2022/03/14Janssen-Cilag International NV; BSP Pharmaceuticals S.p.A.CDE ↗
JYHB2101305Supplement2021/08/11Janssen-Cilag International NV; BSP Pharmaceuticals S.p.A.CDE ↗
No verified English name 12 records · Latest accepted 2025/08/28

Supplement · 12

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2500470Supplement2025/08/28Janssen-Cilag International NV; Janssen-Cilag SpACDE ↗
JYHB2500469Supplement2025/08/28Janssen-Cilag International NV; Janssen-Cilag SpACDE ↗
JYHB2500468Supplement2025/08/28Janssen-Cilag International NV; Janssen-Cilag SpACDE ↗
JYHB2500368Supplement2025/07/16Janssen-Cilag International NV; Janssen-Cilag SpACDE ↗
JYHB2500367Supplement2025/07/16Janssen-Cilag International NV; Janssen-Cilag SpACDE ↗
JYHB2500366Supplement2025/07/16Janssen-Cilag International NV; Janssen-Cilag SpACDE ↗
JYHB2500245Supplement2025/04/28Janssen-Cilag International NV; Janssen-Cilag SpACDE ↗
JYHB2500244Supplement2025/04/28Janssen-Cilag International NV; Janssen-Cilag SpACDE ↗
JYHB2500243Supplement2025/04/28Janssen-Cilag International NV; Janssen-Cilag SpACDE ↗
JYHB2500079Supplement2025/02/17Janssen-Cilag International NV; Janssen-Cilag SpACDE ↗
JYHB2500078Supplement2025/02/17Janssen-Cilag International NV; Janssen-Cilag SpACDE ↗
JYHB2500077Supplement2025/02/17Janssen-Cilag International NV; Janssen-Cilag SpACDE ↗
No verified English name 4 records · Latest accepted 2025/08/22

Import · 2Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JXHS2500089Import2025/08/22Janssen-Cilag International NV; Patheon France; Xian Janssen Pharmaceutical Ltd.CDE ↗
JXHS2500088Import2025/08/22Janssen-Cilag International NV; Patheon France; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYHB2500233Supplement2025/04/23Janssen-Cilag International NV; Patheon FranceCDE ↗
JYHB2500232Supplement2025/04/23Janssen-Cilag International NV; Patheon FranceCDE ↗
No verified English name 9 records · Latest accepted 2025/08/13

Supplement · 8Import re-registration · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYSB2500182Supplement2025/08/13Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2500130Supplement2025/06/05Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2500096Supplement2025/04/07Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2400230Supplement2024/10/17Janssen-Cilag International NV; Cilag AGCDE ↗
JYSZ2400052Import re-registration2024/09/07Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
JYSB2300042Supplement2023/03/07Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2200100Supplement2022/06/20Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2200099Supplement2022/06/16Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2101094Supplement2021/07/27Janssen-Cilag International NV; Cilag AGCDE ↗
No verified English name 5 records · Latest accepted 2025/07/25

Supplement · 2Import · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYSB2500173Supplement2025/07/25Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2500119Supplement2025/05/22Janssen-Cilag International NV; Cilag AGCDE ↗
JXSS2400004Import2024/01/26Janssen-Cilag International NV; Cilag AG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JXSS2300088Import2023/12/08Janssen-Cilag International NV; Cilag AG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JXSS2300080Import2023/10/26Janssen-Cilag International NV; Cilag AG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
No verified English name 1 records · Latest accepted 2025/06/19

Import · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JXHS2500070Import2025/06/19Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
No verified English name 6 records · Latest accepted 2025/04/28

Supplement · 4Import · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2500239Supplement2025/04/28Janssen-Cilag International NV; Cilag AGCDE ↗
JYHB2500238Supplement2025/04/28Janssen-Cilag International NV; Cilag AGCDE ↗
JYHB2400580Supplement2024/11/01Janssen-Cilag International NV; Cilag AGCDE ↗
JYHB2400579Supplement2024/11/01Janssen-Cilag International NV; Cilag AGCDE ↗
JXHS2101067Import2021/11/04Janssen-Cilag International NV; Cilag AG; Xian-Janssen Pharmaceutical Ltd.CDE ↗
JXHS2101066Import2021/11/04Janssen-Cilag International NV; Cilag AG; Xian-Janssen Pharmaceutical Ltd.CDE ↗
No verified English name 18 records · Latest accepted 2025/02/18

Supplement · 14Import re-registration · 4

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2500074Supplement2025/02/18Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2500073Supplement2025/02/18Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2500072Supplement2025/02/18Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2500071Supplement2025/02/18Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2500045Supplement2025/01/25Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2500044Supplement2025/01/25Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2500043Supplement2025/01/25Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2500042Supplement2025/01/25Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHZ2300007Import re-registration2023/01/05Janssen-Cilag International NV; Janssen Pharmaceutica N.V.; Xian-Janssen Pharmaceutical Ltd.CDE ↗
JYHZ2300006Import re-registration2023/01/05Janssen-Cilag International NV; Janssen Pharmaceutica N.V.; Xian-Janssen Pharmaceutical Ltd.CDE ↗
JYHZ2300005Import re-registration2023/01/05Janssen-Cilag International NV; Janssen Pharmaceutica N.V.; Xian-Janssen Pharmaceutical Ltd.CDE ↗
JYHZ2300004Import re-registration2023/01/05Janssen-Cilag International NV; Janssen Pharmaceutica N.V.; Xian-Janssen Pharmaceutical Ltd.CDE ↗
JYHB2200493Supplement2022/09/09Janssen-Cilag International NV; Janssen Pharmaceutica NVCDE ↗
JYHB2200492Supplement2022/09/09Janssen-Cilag International NV; Janssen Pharmaceutica NVCDE ↗
JYHB2101024Supplement2021/04/10Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2101023Supplement2021/04/10Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2101022Supplement2021/04/10Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2101021Supplement2021/04/10Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
No verified English name 2 records · Latest accepted 2025/02/18

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2500076Supplement2025/02/18Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
JYHB2500075Supplement2025/02/18Janssen-Cilag International NV; Janssen Pharmaceutica N.V.CDE ↗
No verified English name 2 records · Latest accepted 2025/01/01

Import · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JXHS2400123Import2025/01/01Janssen-Cilag International NV; Penn Pharmaceutical Services Limited; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
JXHS2400122Import2025/01/01Janssen-Cilag International NV; Penn Pharmaceutical Services Limited; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
No verified English name 2 records · Latest accepted 2023/10/19

Import · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JXSL2300187Import2023/10/19Janssen-Cilag International NV; Xian Janssen Pharmaceutical Ltd.CDE ↗
JXSL2300186Import2023/10/19Janssen-Cilag International NV; Xian Janssen Pharmaceutical Ltd.CDE ↗
No verified English name 2 records · Latest accepted 2023/04/18

Import · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JXHS2300035Import2023/04/18Janssen-Cilag International NV; PATHEON FRANCE; Xian Janssen Pharmaceutical Ltd.CDE ↗
JXHS2300034Import2023/04/18Janssen-Cilag International NV; PATHEON FRANCE; Xian Janssen Pharmaceutical Ltd.CDE ↗
No verified English name 2 records · Latest accepted 2022/09/07

Supplement · 1Import · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JXSB2200113Supplement2022/09/07Janssen-Cilag International NV; Cilag AGCDE ↗
JXSL2101068Import2021/07/24Janssen-Cilag International NV; Johnson & Johnson (China) Investment Ltd.CDE ↗
No verified English name 2 records · Latest accepted 2022/09/07

Supplement · 1Import · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JXHB2200126Supplement2022/09/07Janssen-Cilag International NV; Patheon Pharmaceuticals Inc.; Janssen-Cilag SpACDE ↗
JXHL2101140Import2021/07/26Janssen-Cilag International NV; Johnson & Johnson (China) Investment Ltd.CDE ↗
No verified English name 1 records · Latest accepted 2022/08/29

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JXSB2200104Supplement2022/08/29Janssen-Cilag International NV; Cilag AGCDE ↗
No verified English name 6 records · Latest accepted 2021/10/11

Supplement · 4Import · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYSB2101146Supplement2021/10/11Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2101145Supplement2021/10/11Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2101130Supplement2021/09/13Janssen-Cilag International NV; Cilag AGCDE ↗
JYSB2101129Supplement2021/09/13Janssen-Cilag International NV; Cilag AGCDE ↗
JXSS2100016Import2021/02/19Janssen-Cilag International NV; Cilag AGCDE ↗
JXSS2100015Import2021/02/19Janssen-Cilag International NV; Cilag AGCDE ↗

Changes in the last 90 days

22 events from 2026/08/14 to 2026/11/11. CDE data as of 2026/11/11 06:42; NMPA data as of 2026/11/10 18:31.

This source was last successfully updated at 2026/11/10 18:31; current coverage may be incomplete.

Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately. Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.

Accepted: 21 applicationsNo longer listed under review: 1 application

  1. 2026/11/06No longer listed under review

    Miglustat Capsules

    JYHZ2600139

    Fact date: 2026/11/06 · Site observation date: 2026/11/06

    Accepted: 2026/06/08

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  2. 2026/11/05Accepted

    No verified English name

    JYSB2600311

    Fact date: 2026/11/05 · Site observation date: 2026/11/06

    View source ↗
  3. 2026/11/05Accepted

    No verified English name

    JYSB2600310

    Fact date: 2026/11/05 · Site observation date: 2026/11/06

    View source ↗
  4. 2026/10/23Accepted

    No verified English name

    JYSB2600292

    Fact date: 2026/10/23 · Site observation date: 2026/10/24

    View source ↗
  5. 2026/10/21Accepted

    Canagliflozin Tablets

    JYHB2600564

    Fact date: 2026/10/21 · Site observation date: 2026/10/22

    View source ↗
  6. 2026/10/21Accepted

    Canagliflozin Tablets

    JYHB2600563

    Fact date: 2026/10/21 · Site observation date: 2026/10/22

    View source ↗
  7. 2026/10/21Accepted

    Ibrutinib Capsules

    JYHB2600561

    Fact date: 2026/10/21 · Site observation date: 2026/10/22

    View source ↗
  8. 2026/10/19Accepted

    No verified English name

    JXSS2600097

    Fact date: 2026/10/19 · Site observation date: 2026/10/22

    View source ↗
  9. 2026/10/19Accepted

    No verified English name

    JXSS2600096

    Fact date: 2026/10/19 · Site observation date: 2026/10/22

    View source ↗
  10. 2026/10/16Accepted

    Bortezomib For Injection

    JYHZ2600266

    Fact date: 2026/10/16 · Site observation date: 2026/10/22

    View source ↗
  11. 2026/09/22Accepted

    No verified English name

    JYSB2600261

    Fact date: 2026/09/22 · Site observation date: 2026/10/22

    View source ↗
  12. 2026/09/22Accepted

    Apalutamide Tablets

    JYHB2600530

    Fact date: 2026/09/22 · Site observation date: 2026/10/21

    View source ↗
  13. 2026/09/20Accepted

    Selexipag Tablets

    JXHS2600113

    Fact date: 2026/09/20 · Site observation date: 2026/10/22

    View source ↗
  14. 2026/09/20Accepted

    Selexipag Tablets

    JXHS2600112

    Fact date: 2026/09/20 · Site observation date: 2026/10/22

    View source ↗
  15. 2026/09/20Accepted

    Selexipag Tablets

    JXHS2600111

    Fact date: 2026/09/20 · Site observation date: 2026/10/22

    View source ↗
  16. 2026/09/20Accepted

    Selexipag Tablets

    JXHS2600110

    Fact date: 2026/09/20 · Site observation date: 2026/10/22

    View source ↗
  17. 2026/09/20Accepted

    Selexipag Tablets

    JXHS2600109

    Fact date: 2026/09/20 · Site observation date: 2026/10/22

    View source ↗
  18. 2026/09/20Accepted

    Selexipag Tablets

    JXHS2600108

    Fact date: 2026/09/20 · Site observation date: 2026/10/22

    View source ↗
  19. 2026/09/20Accepted

    Selexipag Tablets

    JXHS2600107

    Fact date: 2026/09/20 · Site observation date: 2026/10/22

    View source ↗
  20. 2026/09/20Accepted

    Selexipag Tablets

    JXHS2600106

    Fact date: 2026/09/20 · Site observation date: 2026/10/22

    View source ↗
  21. 2026/08/17Accepted

    Selexipag Tablets

    JXHS2600092

    Fact date: 2026/08/17 · Site observation date: 2026/10/22

    View source ↗
  22. 2026/08/17Accepted

    Selexipag Tablets

    JXHS2600091

    Fact date: 2026/08/17 · Site observation date: 2026/10/22

    View source ↗

Under review

36 acceptance numbers with this company as first applicant are currently listed as under review by CDE. Source data as of 2026/11/11 06:42.

Under review
Drug Acceptance numberApplication typeAcceptedCompany / applicantView source
No verified English name JYSB2600311Supplement2026/11/05Janssen-Cilag International NV; Cilag AGCDE ↗
No verified English name JYSB2600310Supplement2026/11/05Janssen-Cilag International NV; Cilag AGCDE ↗
No verified English name JYSB2600292Supplement2026/10/23Janssen-Cilag International NV; Cilag AG; Patheon Italia S.p.A.CDE ↗
Canagliflozin Tablets JYHB2600564Supplement2026/10/21Janssen-Cilag International NV; Janssen-Cilag S.p.A.CDE ↗
Canagliflozin Tablets JYHB2600563Supplement2026/10/21Janssen-Cilag International NV; Janssen-Cilag S.p.A.CDE ↗
Ibrutinib Capsules JYHB2600561Supplement2026/10/21Janssen-Cilag International NV; Catalent CTS LLC; Cilag AGCDE ↗
No verified English name JXSS2600097Import2026/10/19Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
No verified English name JXSS2600096Import2026/10/19Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
Bortezomib For Injection JYHZ2600266Import re-registration2026/10/16Janssen-Cilag International NV; BSP Pharmaceuticals S.p.A.; XIAN JANSSEN PHARMACEUTICAL Ltd.CDE ↗
No verified English name JYSB2600261Supplement2026/09/22Janssen-Cilag International NV; Cilag AGCDE ↗
Apalutamide Tablets JYHB2600530Supplement2026/09/22Janssen-Cilag International NV; Janssen Ortho LLC; Catalent Pharma Solutions LLCCDE ↗
Selexipag Tablets JXHS2600113Import2026/09/20Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
Selexipag Tablets JXHS2600112Import2026/09/20Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
Selexipag Tablets JXHS2600111Import2026/09/20Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
Selexipag Tablets JXHS2600110Import2026/09/20Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
Selexipag Tablets JXHS2600109Import2026/09/20Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
Selexipag Tablets JXHS2600108Import2026/09/20Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
Selexipag Tablets JXHS2600107Import2026/09/20Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
Selexipag Tablets JXHS2600106Import2026/09/20Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
Selexipag Tablets JXHS2600092Import2026/08/17Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
Selexipag Tablets JXHS2600091Import2026/08/17Janssen-Cilag International NV; Excella GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
Ibrutinib Capsules JYHZ2600188Import re-registration2026/08/05Janssen-Cilag International NV; Catalent CTS LLC; Cilag AG; Xian-Janssen Pharmaceutical Ltd.CDE ↗
Apalutamide Tablets JXHS2600061Import2026/06/10Janssen-Cilag International NV; Janssen Ortho LLC; Catalent Pharma Solutions LLC; Xian Janssen Pharmaceutical Ltd.CDE ↗
No verified English name JXSS2600045Import2026/06/01Janssen-Cilag International NV; Vetter Pharma-Fertigung GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
No verified English name JXSS2600044Import2026/06/01Janssen-Cilag International NV; Vetter Pharma-Fertigung GmbH & Co. KG; Johnson & Johnson Pharmaceutical Ltd.CDE ↗
No verified English name JYSB2600125Supplement2026/05/14Janssen-Cilag International NV; Cilag AGCDE ↗
No verified English name JYSB2600124Supplement2026/05/14Janssen-Cilag International NV; Cilag AGCDE ↗
No verified English name JYSB2600123Supplement2026/05/14Janssen-Cilag International NV; Cilag AGCDE ↗
No verified English name JYSB2600122Supplement2026/05/14Janssen-Cilag International NV; Cilag AGCDE ↗
Abiraterone Acetate Tablets JYHB2600244Supplement2026/05/07Janssen-Cilag International NV; Patheon Inc.CDE ↗
No verified English name JXSS2600037Import2026/04/16Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
No verified English name JXSS2600036Import2026/04/16Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
No verified English name JXSS2600013Import2026/03/01Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
No verified English name JXSS2600012Import2026/03/01Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd.CDE ↗
No verified English name JYSB2500130Supplement2025/06/05Janssen-Cilag International NV; Cilag AGCDE ↗
No verified English name JYSB2500126Supplement2025/05/31Janssen-Cilag International NV; Cilag AGCDE ↗

Catalogue holder records

11 loaded active catalogue records whose holder name matches this source company name. Source data as of 2026/11/11 06:38. Manufacturer-only records are excluded.

DrugMarketing authorization holderManufacturerApproval numberApprovedCatalogue category (source text)View source
Apalutamide TabletsJanssen-Cilag International NVJanssen Ortho,LLC;Catalent Pharma Solutions, LLC国药准字HJ202000292019/09/05Imported originator drugCDE ↗
No verified English nameJanssen-Cilag International NVJanssen Pharmaceutica N.V.H201800232018/05/17Imported originator drugCDE ↗
No verified English nameJanssen-Cilag International NVJanssen Pharmaceutica N.V.H201800202018/05/17Imported originator drugCDE ↗
No verified English nameJanssen-Cilag International NVJanssen Pharmaceutica N.V.H201800212018/05/17Imported originator drugCDE ↗
No verified English nameJanssen-Cilag International NVJanssen Pharmaceutica N.V.H201800222018/05/17Imported originator drugCDE ↗
Canagliflozin TabletsJanssen-Cilag International NVJanssen Ortho, LLCH201703742017/09/29Imported originator drugCDE ↗
Canagliflozin TabletsJanssen-Cilag International NVJanssen Ortho, LLCH201703752017/09/29Imported originator drugCDE ↗
Simeprevir CapsulesJanssen-Cilag International NVJanssen-Cilag S.p.A.H201703492017/08/24Imported originator drugCDE ↗
Paliperidone Extend-release TabletsJanssen-Cilag International NVJanssen Cilag Manufacturing L.L.C.H201605502008/09/28Imported originator drugCDE ↗
Paliperidone Extend-release TabletsJanssen-Cilag International NVJanssen Cilag Manufacturing L.L.C.H201605492008/09/28Imported originator drugCDE ↗
Decitabine For InjectionJanssen-Cilag International NVPharmachemie B.V.H201812172008/09/28Imported originator drugCDE ↗

Only active catalogue records matching the source holder name are listed. A manufacturer role does not count as a holder record. The catalogue covers only part of the chemical-drug market; source categories do not establish complete market coverage or qualifications.

API registrations

0 loaded active API registrations whose first registered company matches this source company name. Source data as of 2026/11/11 06:40.

NameCompany / applicantRegistration numberStatusSource update dateView source
No matching records were found in the currently loaded source data; coverage dates are listed below.

Only loaded active API registrations not listed as cancelled are shown. A/I are source registration statuses. Records are listed by registration number and do not establish capacity or supply. The register does not identify the associated formulation.

Co-applicant records

28 acceptance records name this company after the first applicant. They are listed separately and are not included in first-applicant drug or filing counts. Source data as of 2026/11/11 06:42.

Co-applicant records
Drug Acceptance numberApplication typeAcceptedCompany / applicantView source
No verified English name JTH2600141Not stated by source2026/07/14Janssen-Cilag SpA; Janssen-Cilag International NV; Qiang Sheng Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2600140Not stated by source2026/07/14Janssen-Cilag SpA; Janssen-Cilag International NV; Qiang Sheng Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTS2600108Not stated by source2026/06/30Lonza AG; Janssen-Cilag International NV; Qiang Sheng Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2500156Not stated by source2025/10/24JANSSEN CILAG S.P.A.; Janssen-Cilag International NV; Xian Yang Sen Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTS2400066Not stated by source2024/08/02Vetter Pharma-Fertigung GmbH & Co. KG; Janssen-Cilag International NV; Qiang Sheng Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTS2400065Not stated by source2024/08/02Vetter Pharma-Fertigung GmbH & Co. KG; Janssen-Cilag International NV; Qiang Sheng Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2400126Not stated by source2024/08/02Excella GmbH & Co KG; Janssen-Cilag International NV; Xian Yang Sen Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2400125Not stated by source2024/08/02Excella GmbH & Co KG; Janssen-Cilag International NV; Xian Yang Sen Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTS2400023Not stated by source2024/03/15Cilag AG; Janssen-Cilag International NV; Xian Yang Sen Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTS2400022Not stated by source2024/03/15Cilag AG; Janssen-Cilag International NV; Xian Yang Sen Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTS2400021Not stated by source2024/03/15Janssen Sciences Ireland UC; Janssen-Cilag International NV; Xian Yang Sen Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTS2300083Not stated by source2023/12/20Cilag AG; Janssen-Cilag International NV; Xian Yang Sen Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTS2300082Not stated by source2023/12/20Janssen Sciences Ireland UC; Janssen-Cilag International NV; Xian Yang Sen Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTS2300058Not stated by source2023/10/30Patheon Manufacturing Services LLC; Janssen-Cilag International NV; Qiang Sheng Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTS2300057Not stated by source2023/10/30Patheon Manufacturing Services LLC; Janssen-Cilag International NV; Qiang Sheng Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTS2300056Not stated by source2023/10/30Janssen Sciences Ireland UC (JSI); Janssen-Cilag International NV; Qiang Sheng Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2300238Not stated by source2023/10/10Janssen-Cilag SpA; Janssen-Cilag International NV; Xian Yang Sen Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2300129Not stated by source2023/05/22Janssen Pharmaceutica N.V.; Janssen-Cilag International NV; Xian Yang Sen Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2300128Not stated by source2023/05/22Janssen Pharmaceutica N.V.; Janssen-Cilag International NV; Xian Yang Sen Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2300127Not stated by source2023/05/22Janssen Pharmaceutica N.V.; Janssen-Cilag International NV; Xian Yang Sen Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTS2200109Not stated by source2022/12/28Patheon Manufacturing Services LLC; Janssen-Cilag International NV; Xian Yang Sen Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTS2200108Not stated by source2022/12/28Patheon Manufacturing Services LLC; Janssen-Cilag International NV; Xian Yang Sen Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTS2200107Not stated by source2022/12/28Janssen Sciences Ireland UC (JSI); Janssen-Cilag International NV; Xian Yang Sen Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTS2200087Not stated by source2022/10/14Cilag AG; Janssen-Cilag International NV; Xian Yang Sen Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTS2200086Not stated by source2022/10/14Janssen Sciences Ireland UC (JSI); Janssen-Cilag International NV; Xian Yang Sen Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTS2100549Not stated by source2021/12/23Janssen Sciences Ireland UC (JSI); Janssen-Cilag International NV; Xian Yang Sen Pharmaceutical Co., Ltd. romanizedCDE ↗
Miglustat Capsules JTH2100700Not stated by source2021/11/25Almac Pharma Services Limited; Janssen-Cilag International NV; Ai Ke Tai Long Pharmaceuticals Trading (Shanghai) Co., Ltd. romanizedCDE ↗
No verified English name JTS2100541Not stated by source2021/11/10Cilag AG; Janssen-Cilag International NV; Xian Yang Sen Pharmaceutical Co., Ltd. romanizedCDE ↗

How current is each source?

CDE acceptances and review
Last successful update: 2026/11/11 06:42
Chemical-drug catalogue
Last successful update: 2026/11/11 06:38
Full API register
Last successful update: 2026/11/11 06:40
NMPA drug delivery notices
Last successful update: 2026/11/10 18:31 · Current coverage may be incomplete

First index-page publication dates: — to —; 0 pages pending. Covers loaded notices only, not a complete historical approval database.

Listed by the company name as recorded in the source, without merging affiliated entities.

This page summarizes loaded records only, without new source queries or collection. Parent companies, subsidiaries, former names and aliases are not merged. Counts from different sources must not be added together. No loaded record does not establish the absence of a filing or registration. Check original records where coverage is incomplete, an update has failed, or a source lies outside the loaded scope.

Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.

Drug names use verified official English names only. Missing names are shown as No verified English name, linking to a Chinese page. Company labels use verified official names, Latin source names, then fixed-rule transliterations marked romanized. Original statutory reference numbers are the sole visible Chinese exception.

Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Chinese free text is not displayed; use the source links or source-name columns in CSV exports.