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N.V. Organon

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.

Page reference 1e2a04905e

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

157 acceptance records as first applicant, grouped into 24 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.

Etoricoxib Tablets 24 records · Latest accepted 2026/10/10

Import re-registration · 16Supplement · 8

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2600262Import re-registration2026/10/10N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2600261Import re-registration2026/10/10N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2600260Import re-registration2026/10/10N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2600259Import re-registration2026/10/10N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2600258Import re-registration2026/10/10N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2600257Import re-registration2026/10/10N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2600256Import re-registration2026/10/10N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2600255Import re-registration2026/10/10N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2200118Import re-registration2022/05/10N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2200117Import re-registration2022/05/10N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2200116Import re-registration2022/05/10N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2200115Import re-registration2022/05/10N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2200114Import re-registration2022/05/10N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2200113Import re-registration2022/05/10N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2200112Import re-registration2022/05/10N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2200111Import re-registration2022/05/10N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHB2200060Supplement2022/01/27N.V. Organon; Rovi Pharma Industrial Services S.A.CDE ↗
JYHB2200059Supplement2022/01/27N.V. Organon; Rovi Pharma Industrial Services S.A.CDE ↗
JYHB2200058Supplement2022/01/27N.V. Organon; Rovi Pharma Industrial Services S.A.CDE ↗
JYHB2200057Supplement2022/01/27N.V. Organon; Rovi Pharma Industrial Services S.A.CDE ↗
JYHB2200056Supplement2022/01/27N.V. Organon; Rovi Pharma Industrial Services S.A.CDE ↗
JYHB2200055Supplement2022/01/27N.V. Organon; Rovi Pharma Industrial Services S.A.CDE ↗
JYHB2200054Supplement2022/01/27N.V. Organon; Rovi Pharma Industrial Services S.A.CDE ↗
JYHB2200053Supplement2022/01/27N.V. Organon; Rovi Pharma Industrial Services S.A.CDE ↗
Simvastatin Tablets 12 records · Latest accepted 2026/09/21

Import re-registration · 6Supplement · 6

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2600230Import re-registration2026/09/21N.V. Organon; Organon Pharma (UK)Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2600229Import re-registration2026/09/21N.V. Organon; Organon Pharma (UK)Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2600101Import re-registration2026/04/22N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2600100Import re-registration2026/04/22N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHB2400017Supplement2024/01/12N.V. Organon; Organon Pharma (UK)LimitedCDE ↗
JYHB2400016Supplement2024/01/12N.V. Organon; Organon Pharma (UK)LimitedCDE ↗
JYHZ2200139Import re-registration2022/06/13N.V. Organon; Organon Pharma (UK)Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2200138Import re-registration2022/06/13N.V. Organon; Organon Pharma (UK)Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHB2200167Supplement2022/03/29N.V. Organon; Organon Pharma(UK) LimitedCDE ↗
JYHB2200166Supplement2022/03/29N.V.Organon; Organon Pharma (UK)LimitedCDE ↗
JYHB2200165Supplement2022/03/29N.V. Organon; Organon Pharma(UK) LimitedCDE ↗
JYHB2200164Supplement2022/03/29N.V. Organon; Organon Pharma (UK)LimitedCDE ↗
Ezetimibe and Simvastatin Tablets 9 records · Latest accepted 2026/09/16

Supplement · 7Import re-registration · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2600521Supplement2026/09/16N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH); Organon Pharma (UK) LimitedCDE ↗
JYHB2600520Supplement2026/09/16N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH); Organon Pharma (UK) LimitedCDE ↗
JYHB2500093Supplement2025/02/26N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH); Organon Pharma (UK) LimitedCDE ↗
JYHB2500092Supplement2025/02/26N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH); Organon Pharma (UK) LimitedCDE ↗
JYHB2400410Supplement2024/08/01N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH)CDE ↗
JYHZ2200346Import re-registration2022/12/23N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH); Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2200345Import re-registration2022/12/23N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH); Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHB2200304Supplement2022/06/17N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH)CDE ↗
JYHB2200303Supplement2022/06/17N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH)CDE ↗
Ganirelix Injection 5 records · Latest accepted 2026/09/16

Supplement · 4Import re-registration · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2600523Supplement2026/09/16N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KGCDE ↗
JYHB2400407Supplement2024/07/30N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KGCDE ↗
JYHZ2200259Import re-registration2022/09/24N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHB2200279Supplement2022/05/31N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KGCDE ↗
JYHB2101596Supplement2021/12/17N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KGCDE ↗
No verified English name 2 records · Latest accepted 2026/09/10

Not stated by source · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JTS2600142Not stated by source2026/09/10N.V. Organon; Ou Jia Long (Shanghai) Pharmaceuticals Trading Co., Ltd. romanizedCDE ↗
JTS2600064Not stated by source2026/04/22N.V. Organon; Ou Jia Long (Shanghai) Pharmaceuticals Trading Co., Ltd. romanizedCDE ↗
No verified English name 5 records · Latest accepted 2026/08/27

Supplement · 5

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2600494Supplement2026/08/27N.V. Organon; Name not romanized; Name not romanizedCDE ↗
JYHB2500641Supplement2025/11/27N.V. Organon; Name not romanized; Name not romanizedCDE ↗
JYHB2400184Supplement2024/04/26N.V. Organon; MSD International GmbH (Puerto Rico Branch) LLC,MSD International GmbH (Singapore Branch)CDE ↗
JYHB2300581Supplement2023/10/18N.V. Organon; MSD International GmbH (Puerto Rico Branch) LLCCDE ↗
JXHB2300023Supplement2023/02/02N.V. Organon; MSD International GmbH (Puerto Rico Branch) LLCCDE ↗
No verified English name 5 records · Latest accepted 2026/08/27

Supplement · 5

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2600493Supplement2026/08/27N.V. Organon; Name not romanized; Name not romanizedCDE ↗
JYHB2500642Supplement2025/11/27N.V. Organon; Name not romanized; Name not romanizedCDE ↗
JYHB2400185Supplement2024/04/26N.V. Organon; MSD International GmbH (Puerto Rico Branch) LLC,MSD International GmbH (Singapore Branch)CDE ↗
JYHB2300582Supplement2023/10/18N.V. Organon; MSD International GmbH (Puerto Rico Branch) LLCCDE ↗
JXHB2300024Supplement2023/02/02N.V. Organon; MSD International GmbH (Puerto Rico Branch) LLCCDE ↗
Sugammadex Sodium Injection 1 records · Latest accepted 2026/03/31

Not stated by source · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JTH2600069Not stated by source2026/03/31N.V. Organon; Merck Sharp & Dohme B.V.; Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanizedCDE ↗
Losartan Potassium and Hydrochlorothiazide Tablets 16 records · Latest accepted 2026/03/19

Import re-registration · 4Supplement · 12

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2600058Import re-registration2026/03/19N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2600057Import re-registration2026/03/19N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHB2500374Supplement2025/07/18N.V.Organon; Organon Pharma (UK) LimitedCDE ↗
JYHB2500373Supplement2025/07/18N.V.Organon; Organon Pharma (UK) LimitedCDE ↗
JYHB2300192Supplement2023/03/24N.V.Organon; Organon Pharma(UK) LimitedCDE ↗
JYHB2300191Supplement2023/03/24N.V.Organon; Organon Pharma(UK) LimitedCDE ↗
JYHZ2200204Import re-registration2022/07/18N.V.Organon; Organon Pharma(UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2200203Import re-registration2022/07/18N.V.Organon; Organon Pharma(UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHB2200114Supplement2022/03/03N.V.Organon; Organon Pharma(UK) LimitedCDE ↗
JYHB2200113Supplement2022/03/03N.V.Organon; Organon Pharma(UK) LimitedCDE ↗
JYHB2200112Supplement2022/03/03N.V.Organon; Organon Pharma(UK) LimitedCDE ↗
JYHB2200111Supplement2022/03/03N.V.Organon; Organon Pharma(UK) LimitedCDE ↗
JYHB2101114Supplement2021/05/20N.V.Organon; Organon Pharma(UK) LimitedCDE ↗
JYHB2101113Supplement2021/05/20N.V.Organon; Organon Pharma(UK) LimitedCDE ↗
JYHB2101111Supplement2021/05/20N.V.Organon; Organon Pharma(UK) LimitedCDE ↗
JYHB2101109Supplement2021/05/20N.V.Organon; Organon Pharma(UK) LimitedCDE ↗
No verified English name 6 records · Latest accepted 2026/01/09

Supplement · 5Import re-registration · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2600027Supplement2026/01/09N.V. OrganonCDE ↗
JYHB2400598Supplement2024/11/12N.V. OrganonCDE ↗
JYHB2400347Supplement2024/07/08N.V. OrganonCDE ↗
JYHZ2300093Import re-registration2023/02/22N.V. Organon; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHB2300043Supplement2023/01/12N.V. OrganonCDE ↗
JYHB2200379Supplement2022/07/21N.V. OrganonCDE ↗
Desogestrel and Ethinylestradiol Tablets 8 records · Latest accepted 2025/12/30

Import re-registration · 4Supplement · 4

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2500309Import re-registration2025/12/30N.V. Organon; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2500301Import re-registration2025/12/25N.V. Organon; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHB2500335Supplement2025/06/24N.V. OrganonCDE ↗
JYHB2500325Supplement2025/06/14N.V. OrganonCDE ↗
JYHB2300314Supplement2023/05/26N.V. OrganonCDE ↗
JYHB2300239Supplement2023/04/15N.V. OrganonCDE ↗
JYHZ2100616Import re-registration2021/09/02N.V. Organon; Bayer Healthcare Co. LtdCDE ↗
JYHZ2100542Import re-registration2021/05/19N.V. Organon; Bayer Healthcare Co. Ltd.CDE ↗
Desloratadine Tablets 6 records · Latest accepted 2025/09/17

Supplement · 4Import re-registration · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2500490Supplement2025/09/17N.V. Organon; Organon Heist bvCDE ↗
JYHB2500489Supplement2025/09/17N.V. Organon; Organon Heist bvCDE ↗
JYHZ2300109Import re-registration2023/03/02N.V. Organon; Schering-Plough Labo N. V.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2300108Import re-registration2023/03/02N.V. Organon; Schering-Plough Labo N. V.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHB2101582Supplement2021/12/10N.V.Organon; Schering-Plough Labo N.V.CDE ↗
JYHB2101581Supplement2021/12/10N.V.Organon; Schering-Plough Labo N.V.CDE ↗
Tibolone Tablets 2 records · Latest accepted 2025/07/30

Import re-registration · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2500161Import re-registration2025/07/30N.V.Organon; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2100509Import re-registration2021/03/29N.V.Organon; MSD R&D (China) Co. Ltd.CDE ↗
No verified English name 14 records · Latest accepted 2025/06/14

Supplement · 12Import re-registration · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYSB2500134Supplement2025/06/14N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KGCDE ↗
JYSB2500133Supplement2025/06/14N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KGCDE ↗
JYSB2400270Supplement2024/12/25N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KGCDE ↗
JYSB2400269Supplement2024/12/25N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KGCDE ↗
JYSZ2400018Import re-registration2024/04/11N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYSZ2400017Import re-registration2024/04/11N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYSB2400061Supplement2024/03/20N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KGCDE ↗
JYSB2400060Supplement2024/03/20N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KGCDE ↗
JYSB2300096Supplement2023/05/23N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KGCDE ↗
JYSB2300095Supplement2023/05/23N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KGCDE ↗
JYSB2200195Supplement2022/10/11N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KGCDE ↗
JYSB2200194Supplement2022/10/11N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KGCDE ↗
JYSB2200035Supplement2022/03/03N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KGCDE ↗
JYSB2200034Supplement2022/03/03N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KGCDE ↗
Montelukast Sodium Chewable Tablets 10 records · Latest accepted 2025/05/28

Supplement · 6Import re-registration · 4

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2500293Supplement2025/05/28N.V. Organon; Organon Pharma (UK) LimitedCDE ↗
JYHB2500292Supplement2025/05/28N.V. Organon; Organon Pharma (UK) LimitedCDE ↗
JYHZ2200190Import re-registration2022/07/05N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2200189Import re-registration2022/07/05N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2200188Import re-registration2022/07/05N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2200187Import re-registration2022/07/05N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHB2200252Supplement2022/05/06N.V. Organon; Organon Pharma (UK) LimitedCDE ↗
JYHB2200251Supplement2022/05/06N.V. Organon; Organon Pharma (UK) LimitedCDE ↗
JYHB2200250Supplement2022/05/06N.V. Organon; Organon Pharma (UK) LimitedCDE ↗
JYHB2200249Supplement2022/05/06N.V. Organon; Organon Pharma (UK) LimitedCDE ↗
Montelukast Sodium Tablets 5 records · Latest accepted 2025/05/28

Supplement · 3Import re-registration · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2500291Supplement2025/05/28N.V. Organon; Organon Pharma (UK) LimitedCDE ↗
JYHZ2200163Import re-registration2022/06/24N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2200162Import re-registration2022/06/24N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHB2200116Supplement2022/03/03N.V. Organon; Organon Pharma (UK) LimitedCDE ↗
JYHB2200115Supplement2022/03/03N.V. Organon; Organon Pharma (UK) LimitedCDE ↗
Alendronate Sodium Tablets 5 records · Latest accepted 2025/03/12

Supplement · 3Import re-registration · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2500146Supplement2025/03/12N.V. Organon; Savio Industrial S.r.LCDE ↗
JYHZ2300138Import re-registration2023/03/17N.V. Organon; Savio Industrial S.r.L; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2300137Import re-registration2023/03/17N.V. Organon; Savio Industrial S.r.L; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHB2200120Supplement2022/03/04N.V. Organon; Savio Industrial S.r.LCDE ↗
JYHB2200119Supplement2022/03/04N.V. Organon; Savio Industrial S.r.LCDE ↗
No verified English name 7 records · Latest accepted 2024/06/29

Supplement · 4Import re-registration · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2400328Supplement2024/06/29N.V. Organon; Rovi Pharma Industrial Services S.A.CDE ↗
JYHZ2200240Import re-registration2022/09/01N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2200239Import re-registration2022/09/01N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2200238Import re-registration2022/09/01N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHB2200149Supplement2022/03/24N.V. Organon; Rovi Pharma Industrial Services S.A.CDE ↗
JYHB2200148Supplement2022/03/24N.V. Organon; Rovi Pharma Industrial Services S.A.CDE ↗
JYHB2200147Supplement2022/03/24N.V. Organon; Rovi Pharma Industrial Services S.A.CDE ↗
No verified English name 5 records · Latest accepted 2024/06/29

Supplement · 3Import re-registration · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2400327Supplement2024/06/29N.V. Organon; Rovi Pharma Industrial Services S.A.CDE ↗
JYHZ2300116Import re-registration2023/03/04N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2300115Import re-registration2023/03/04N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHB2200179Supplement2022/04/06N.V. Organon; Rovi Pharma Industrial Services S.A.CDE ↗
JYHB2200178Supplement2022/04/06N.V. Organon; Rovi Pharma Industrial Services S.A.CDE ↗
No verified English name 3 records · Latest accepted 2023/08/23

Supplement · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHB2300465Supplement2023/08/23N.V. Organon; Anesta LLCCDE ↗
JYHB2300464Supplement2023/08/23N.V. Organon; Anesta LLCCDE ↗
JYHB2300463Supplement2023/08/23N.V. Organon; Anesta LLCCDE ↗
Mirtazapine Tablets 3 records · Latest accepted 2023/06/21

Import re-registration · 2Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2300265Import re-registration2023/06/21N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2300264Import re-registration2023/06/21N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHB2200042Supplement2022/01/21N.V. Organon; Merck Sharp & Dohme Ltd.CDE ↗
No verified English name 2 records · Latest accepted 2023/02/11

Import re-registration · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHZ2300061Import re-registration2023/02/11N.V. Organon; Anesta LLC; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
JYHZ2300060Import re-registration2023/02/11N.V. Organon; Anesta LLC; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
No verified English name 1 records · Latest accepted 2021/08/19

Not stated by source · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JTS2100511Not stated by source2021/08/19N.V. Organon; Hangzhou Mo Sha Dong Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name 1 records · Latest accepted 2021/08/19

Not stated by source · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JTS2100512Not stated by source2021/08/19N.V. Organon; Hangzhou Mo Sha Dong Pharmaceutical Co., Ltd. romanizedCDE ↗

Changes in the last 90 days

18 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: 16 applicationsNo longer listed under review: 2 applications

  1. 2026/10/31No longer listed under review

    No verified English name

    JYHB2500642

    Fact date: 2026/10/31 · Site observation date: 2026/10/31

    Accepted: 2025/11/27

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

    View source ↗
  2. 2026/10/31No longer listed under review

    No verified English name

    JYHB2500641

    Fact date: 2026/10/31 · Site observation date: 2026/10/31

    Accepted: 2025/11/27

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

    View source ↗
  3. 2026/10/10Accepted

    Etoricoxib Tablets

    JYHZ2600262

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

    View source ↗
  4. 2026/10/10Accepted

    Etoricoxib Tablets

    JYHZ2600261

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

    View source ↗
  5. 2026/10/10Accepted

    Etoricoxib Tablets

    JYHZ2600260

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

    View source ↗
  6. 2026/10/10Accepted

    Etoricoxib Tablets

    JYHZ2600259

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

    View source ↗
  7. 2026/10/10Accepted

    Etoricoxib Tablets

    JYHZ2600258

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

    View source ↗
  8. 2026/10/10Accepted

    Etoricoxib Tablets

    JYHZ2600257

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

    View source ↗
  9. 2026/10/10Accepted

    Etoricoxib Tablets

    JYHZ2600256

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

    View source ↗
  10. 2026/10/10Accepted

    Etoricoxib Tablets

    JYHZ2600255

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

    View source ↗
  11. 2026/09/21Accepted

    Simvastatin Tablets

    JYHZ2600230

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

    View source ↗
  12. 2026/09/21Accepted

    Simvastatin Tablets

    JYHZ2600229

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

    View source ↗
  13. 2026/09/16Accepted

    Ganirelix Injection

    JYHB2600523

    Fact date: 2026/09/16 · Site observation date: 2026/10/22

    View source ↗
  14. 2026/09/16Accepted

    Ezetimibe and Simvastatin Tablets

    JYHB2600521

    Fact date: 2026/09/16 · Site observation date: 2026/10/22

    View source ↗
  15. 2026/09/16Accepted

    Ezetimibe and Simvastatin Tablets

    JYHB2600520

    Fact date: 2026/09/16 · Site observation date: 2026/10/22

    View source ↗
  16. 2026/09/10Accepted

    No verified English name

    JTS2600142

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

    View source ↗
  17. 2026/08/27Accepted

    No verified English name

    JYHB2600494

    Fact date: 2026/08/27 · Site observation date: 2026/10/22

    View source ↗
  18. 2026/08/27Accepted

    No verified English name

    JYHB2600493

    Fact date: 2026/08/27 · Site observation date: 2026/10/22

    View source ↗

Under review

17 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
Etoricoxib Tablets JYHZ2600262Import re-registration2026/10/10N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
Etoricoxib Tablets JYHZ2600261Import re-registration2026/10/10N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
Etoricoxib Tablets JYHZ2600260Import re-registration2026/10/10N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
Etoricoxib Tablets JYHZ2600259Import re-registration2026/10/10N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
Etoricoxib Tablets JYHZ2600258Import re-registration2026/10/10N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
Etoricoxib Tablets JYHZ2600257Import re-registration2026/10/10N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
Etoricoxib Tablets JYHZ2600256Import re-registration2026/10/10N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
Etoricoxib Tablets JYHZ2600255Import re-registration2026/10/10N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
Simvastatin Tablets JYHZ2600230Import re-registration2026/09/21N.V. Organon; Organon Pharma (UK)Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
Simvastatin Tablets JYHZ2600229Import re-registration2026/09/21N.V. Organon; Organon Pharma (UK)Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd.CDE ↗
Ganirelix Injection JYHB2600523Supplement2026/09/16N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KGCDE ↗
Ezetimibe and Simvastatin Tablets JYHB2600521Supplement2026/09/16N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH); Organon Pharma (UK) LimitedCDE ↗
Ezetimibe and Simvastatin Tablets JYHB2600520Supplement2026/09/16N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH); Organon Pharma (UK) LimitedCDE ↗
No verified English name JYHB2600494Supplement2026/08/27N.V. Organon; Name not romanized; Name not romanizedCDE ↗
No verified English name JYHB2600493Supplement2026/08/27N.V. Organon; Name not romanized; Name not romanizedCDE ↗
No verified English name JYSB2500134Supplement2025/06/14N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KGCDE ↗
No verified English name JYSB2500133Supplement2025/06/14N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KGCDE ↗

Catalogue holder records

6 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
No verified English nameN.V. OrganonAnesta LLCH20160677; H201606882011/08/25Imported originator drugCDE ↗
No verified English nameN.V. OrganonAnesta LLCH201606762011/08/25Imported originator drugCDE ↗
Mirtazapine TabletsN.V. OrganonN.V. OrganonH20140031;H201505402001/02/05Imported originator drugCDE ↗
Rocuronium Bromide InjectionN.V. OrganonHameln Pharmaceuticals GmbHH201408471997/01/31Imported originator drugCDE ↗
Tibolone TabletsN.V.OrganonN.V.OrganonH201605751990/11/26Imported originator drugCDE ↗
Desogestrel and Ethinylestradiol TabletsN.V.OrganonN.V.OrganonH201711761989/04/18Imported 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

11 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 JTH2600204Not stated by source2026/09/23Aspen Oss BV; N.V. Organon; Ou Jia Long (Shanghai) Pharmaceuticals Trading Co., Ltd. romanizedCDE ↗
No verified English name JTH2600203Not stated by source2026/09/23Aspen Oss BV; N.V. Organon; Ou Jia Long (Shanghai) Pharmaceuticals Trading Co., Ltd. romanizedCDE ↗
Sugammadex Sodium Injection JYHB2600367Supplement2026/07/02Merck Sharp & Dohme B.V.; N.V. OrganonCDE ↗
Posaconazole Enteric-coated Tablets JYHB2500399Supplement2025/08/02Merck Sharp & Dohme B.V.; N.V. OrganonCDE ↗
Posaconazole Enteric-coated Tablets JYHB2400433Supplement2024/08/07Merck Sharp & Dohme B.V.; N.V. OrganonCDE ↗
Posaconazole Enteric-coated Tablets JYHB2400381Supplement2024/07/23Merck Sharp & Dohme B.V.; N.V. OrganonCDE ↗
Posaconazole Enteric-coated Tablets JYHB2300729Supplement2023/12/16Merck Sharp & Dohme B.V.; N.V. OrganonCDE ↗
Posaconazole Enteric-coated Tablets JYHZ2300099Import re-registration2023/02/23Merck Sharp & Dohme B.V.; N.V. Organon; Name not romanizedCDE ↗
Posaconazole Enteric-coated Tablets JYHB2200482Supplement2022/09/04Merck Sharp & Dohme B.V.; N.V.OrganonCDE ↗
Posaconazole Enteric-coated Tablets JYHB2200261Supplement2022/05/11Merck Sharp & Dohme B.V.; N.V.OrganonCDE ↗
Posaconazole Enteric-coated Tablets JYHB2100138Supplement2021/02/11Merck Sharp & Dohme B.V.; N.V.OrganonCDE ↗

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.