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
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
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHZ2600262 | Import re-registration | 2026/10/10 | N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2600261 | Import re-registration | 2026/10/10 | N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2600260 | Import re-registration | 2026/10/10 | N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2600259 | Import re-registration | 2026/10/10 | N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2600258 | Import re-registration | 2026/10/10 | N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2600257 | Import re-registration | 2026/10/10 | N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2600256 | Import re-registration | 2026/10/10 | N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2600255 | Import re-registration | 2026/10/10 | N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2200118 | Import re-registration | 2022/05/10 | N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2200117 | Import re-registration | 2022/05/10 | N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2200116 | Import re-registration | 2022/05/10 | N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2200115 | Import re-registration | 2022/05/10 | N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2200114 | Import re-registration | 2022/05/10 | N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2200113 | Import re-registration | 2022/05/10 | N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2200112 | Import re-registration | 2022/05/10 | N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2200111 | Import re-registration | 2022/05/10 | N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHB2200060 | Supplement | 2022/01/27 | N.V. Organon; Rovi Pharma Industrial Services S.A. | CDE ↗ |
| JYHB2200059 | Supplement | 2022/01/27 | N.V. Organon; Rovi Pharma Industrial Services S.A. | CDE ↗ |
| JYHB2200058 | Supplement | 2022/01/27 | N.V. Organon; Rovi Pharma Industrial Services S.A. | CDE ↗ |
| JYHB2200057 | Supplement | 2022/01/27 | N.V. Organon; Rovi Pharma Industrial Services S.A. | CDE ↗ |
| JYHB2200056 | Supplement | 2022/01/27 | N.V. Organon; Rovi Pharma Industrial Services S.A. | CDE ↗ |
| JYHB2200055 | Supplement | 2022/01/27 | N.V. Organon; Rovi Pharma Industrial Services S.A. | CDE ↗ |
| JYHB2200054 | Supplement | 2022/01/27 | N.V. Organon; Rovi Pharma Industrial Services S.A. | CDE ↗ |
| JYHB2200053 | Supplement | 2022/01/27 | N.V. Organon; Rovi Pharma Industrial Services S.A. | CDE ↗ |
Simvastatin Tablets 12 records · Latest accepted 2026/09/21
Import re-registration · 6Supplement · 6
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHZ2600230 | Import re-registration | 2026/09/21 | N.V. Organon; Organon Pharma (UK)Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2600229 | Import re-registration | 2026/09/21 | N.V. Organon; Organon Pharma (UK)Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2600101 | Import re-registration | 2026/04/22 | N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2600100 | Import re-registration | 2026/04/22 | N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHB2400017 | Supplement | 2024/01/12 | N.V. Organon; Organon Pharma (UK)Limited | CDE ↗ |
| JYHB2400016 | Supplement | 2024/01/12 | N.V. Organon; Organon Pharma (UK)Limited | CDE ↗ |
| JYHZ2200139 | Import re-registration | 2022/06/13 | N.V. Organon; Organon Pharma (UK)Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2200138 | Import re-registration | 2022/06/13 | N.V. Organon; Organon Pharma (UK)Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHB2200167 | Supplement | 2022/03/29 | N.V. Organon; Organon Pharma(UK) Limited | CDE ↗ |
| JYHB2200166 | Supplement | 2022/03/29 | N.V.Organon; Organon Pharma (UK)Limited | CDE ↗ |
| JYHB2200165 | Supplement | 2022/03/29 | N.V. Organon; Organon Pharma(UK) Limited | CDE ↗ |
| JYHB2200164 | Supplement | 2022/03/29 | N.V. Organon; Organon Pharma (UK)Limited | CDE ↗ |
Ezetimibe and Simvastatin Tablets 9 records · Latest accepted 2026/09/16
Supplement · 7Import re-registration · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHB2600521 | Supplement | 2026/09/16 | N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH); Organon Pharma (UK) Limited | CDE ↗ |
| JYHB2600520 | Supplement | 2026/09/16 | N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH); Organon Pharma (UK) Limited | CDE ↗ |
| JYHB2500093 | Supplement | 2025/02/26 | N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH); Organon Pharma (UK) Limited | CDE ↗ |
| JYHB2500092 | Supplement | 2025/02/26 | N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH); Organon Pharma (UK) Limited | CDE ↗ |
| JYHB2400410 | Supplement | 2024/08/01 | N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH) | CDE ↗ |
| JYHZ2200346 | Import re-registration | 2022/12/23 | N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH); Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2200345 | Import re-registration | 2022/12/23 | N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH); Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHB2200304 | Supplement | 2022/06/17 | N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH) | CDE ↗ |
| JYHB2200303 | Supplement | 2022/06/17 | N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH) | CDE ↗ |
Ganirelix Injection 5 records · Latest accepted 2026/09/16
Supplement · 4Import re-registration · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHB2600523 | Supplement | 2026/09/16 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG | CDE ↗ |
| JYHB2400407 | Supplement | 2024/07/30 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG | CDE ↗ |
| JYHZ2200259 | Import re-registration | 2022/09/24 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHB2200279 | Supplement | 2022/05/31 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG | CDE ↗ |
| JYHB2101596 | Supplement | 2021/12/17 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG | CDE ↗ |
No verified English name 2 records · Latest accepted 2026/09/10
Not stated by source · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JTS2600142 | Not stated by source | 2026/09/10 | N.V. Organon; Ou Jia Long (Shanghai) Pharmaceuticals Trading Co., Ltd. romanized | CDE ↗ |
| JTS2600064 | Not stated by source | 2026/04/22 | N.V. Organon; Ou Jia Long (Shanghai) Pharmaceuticals Trading Co., Ltd. romanized | CDE ↗ |
No verified English name 5 records · Latest accepted 2026/08/27
Supplement · 5
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHB2600494 | Supplement | 2026/08/27 | N.V. Organon; Name not romanized; Name not romanized | CDE ↗ |
| JYHB2500641 | Supplement | 2025/11/27 | N.V. Organon; Name not romanized; Name not romanized | CDE ↗ |
| JYHB2400184 | Supplement | 2024/04/26 | N.V. Organon; MSD International GmbH (Puerto Rico Branch) LLC,MSD International GmbH (Singapore Branch) | CDE ↗ |
| JYHB2300581 | Supplement | 2023/10/18 | N.V. Organon; MSD International GmbH (Puerto Rico Branch) LLC | CDE ↗ |
| JXHB2300023 | Supplement | 2023/02/02 | N.V. Organon; MSD International GmbH (Puerto Rico Branch) LLC | CDE ↗ |
No verified English name 5 records · Latest accepted 2026/08/27
Supplement · 5
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHB2600493 | Supplement | 2026/08/27 | N.V. Organon; Name not romanized; Name not romanized | CDE ↗ |
| JYHB2500642 | Supplement | 2025/11/27 | N.V. Organon; Name not romanized; Name not romanized | CDE ↗ |
| JYHB2400185 | Supplement | 2024/04/26 | N.V. Organon; MSD International GmbH (Puerto Rico Branch) LLC,MSD International GmbH (Singapore Branch) | CDE ↗ |
| JYHB2300582 | Supplement | 2023/10/18 | N.V. Organon; MSD International GmbH (Puerto Rico Branch) LLC | CDE ↗ |
| JXHB2300024 | Supplement | 2023/02/02 | N.V. Organon; MSD International GmbH (Puerto Rico Branch) LLC | CDE ↗ |
Sugammadex Sodium Injection 1 records · Latest accepted 2026/03/31
Not stated by source · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JTH2600069 | Not stated by source | 2026/03/31 | N.V. Organon; Merck Sharp & Dohme B.V.; Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized | CDE ↗ |
Losartan Potassium and Hydrochlorothiazide Tablets 16 records · Latest accepted 2026/03/19
Import re-registration · 4Supplement · 12
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHZ2600058 | Import re-registration | 2026/03/19 | N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2600057 | Import re-registration | 2026/03/19 | N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHB2500374 | Supplement | 2025/07/18 | N.V.Organon; Organon Pharma (UK) Limited | CDE ↗ |
| JYHB2500373 | Supplement | 2025/07/18 | N.V.Organon; Organon Pharma (UK) Limited | CDE ↗ |
| JYHB2300192 | Supplement | 2023/03/24 | N.V.Organon; Organon Pharma(UK) Limited | CDE ↗ |
| JYHB2300191 | Supplement | 2023/03/24 | N.V.Organon; Organon Pharma(UK) Limited | CDE ↗ |
| JYHZ2200204 | Import re-registration | 2022/07/18 | N.V.Organon; Organon Pharma(UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2200203 | Import re-registration | 2022/07/18 | N.V.Organon; Organon Pharma(UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHB2200114 | Supplement | 2022/03/03 | N.V.Organon; Organon Pharma(UK) Limited | CDE ↗ |
| JYHB2200113 | Supplement | 2022/03/03 | N.V.Organon; Organon Pharma(UK) Limited | CDE ↗ |
| JYHB2200112 | Supplement | 2022/03/03 | N.V.Organon; Organon Pharma(UK) Limited | CDE ↗ |
| JYHB2200111 | Supplement | 2022/03/03 | N.V.Organon; Organon Pharma(UK) Limited | CDE ↗ |
| JYHB2101114 | Supplement | 2021/05/20 | N.V.Organon; Organon Pharma(UK) Limited | CDE ↗ |
| JYHB2101113 | Supplement | 2021/05/20 | N.V.Organon; Organon Pharma(UK) Limited | CDE ↗ |
| JYHB2101111 | Supplement | 2021/05/20 | N.V.Organon; Organon Pharma(UK) Limited | CDE ↗ |
| JYHB2101109 | Supplement | 2021/05/20 | N.V.Organon; Organon Pharma(UK) Limited | CDE ↗ |
No verified English name 6 records · Latest accepted 2026/01/09
Supplement · 5Import re-registration · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHB2600027 | Supplement | 2026/01/09 | N.V. Organon | CDE ↗ |
| JYHB2400598 | Supplement | 2024/11/12 | N.V. Organon | CDE ↗ |
| JYHB2400347 | Supplement | 2024/07/08 | N.V. Organon | CDE ↗ |
| JYHZ2300093 | Import re-registration | 2023/02/22 | N.V. Organon; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHB2300043 | Supplement | 2023/01/12 | N.V. Organon | CDE ↗ |
| JYHB2200379 | Supplement | 2022/07/21 | N.V. Organon | CDE ↗ |
Desogestrel and Ethinylestradiol Tablets 8 records · Latest accepted 2025/12/30
Import re-registration · 4Supplement · 4
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHZ2500309 | Import re-registration | 2025/12/30 | N.V. Organon; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2500301 | Import re-registration | 2025/12/25 | N.V. Organon; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHB2500335 | Supplement | 2025/06/24 | N.V. Organon | CDE ↗ |
| JYHB2500325 | Supplement | 2025/06/14 | N.V. Organon | CDE ↗ |
| JYHB2300314 | Supplement | 2023/05/26 | N.V. Organon | CDE ↗ |
| JYHB2300239 | Supplement | 2023/04/15 | N.V. Organon | CDE ↗ |
| JYHZ2100616 | Import re-registration | 2021/09/02 | N.V. Organon; Bayer Healthcare Co. Ltd | CDE ↗ |
| JYHZ2100542 | Import re-registration | 2021/05/19 | N.V. Organon; Bayer Healthcare Co. Ltd. | CDE ↗ |
Desloratadine Tablets 6 records · Latest accepted 2025/09/17
Supplement · 4Import re-registration · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHB2500490 | Supplement | 2025/09/17 | N.V. Organon; Organon Heist bv | CDE ↗ |
| JYHB2500489 | Supplement | 2025/09/17 | N.V. Organon; Organon Heist bv | CDE ↗ |
| JYHZ2300109 | Import re-registration | 2023/03/02 | N.V. Organon; Schering-Plough Labo N. V.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2300108 | Import re-registration | 2023/03/02 | N.V. Organon; Schering-Plough Labo N. V.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHB2101582 | Supplement | 2021/12/10 | N.V.Organon; Schering-Plough Labo N.V. | CDE ↗ |
| JYHB2101581 | Supplement | 2021/12/10 | N.V.Organon; Schering-Plough Labo N.V. | CDE ↗ |
Tibolone Tablets 2 records · Latest accepted 2025/07/30
Import re-registration · 2
No verified English name 14 records · Latest accepted 2025/06/14
Supplement · 12Import re-registration · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYSB2500134 | Supplement | 2025/06/14 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG | CDE ↗ |
| JYSB2500133 | Supplement | 2025/06/14 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG | CDE ↗ |
| JYSB2400270 | Supplement | 2024/12/25 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG | CDE ↗ |
| JYSB2400269 | Supplement | 2024/12/25 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG | CDE ↗ |
| JYSZ2400018 | Import re-registration | 2024/04/11 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYSZ2400017 | Import re-registration | 2024/04/11 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYSB2400061 | Supplement | 2024/03/20 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG | CDE ↗ |
| JYSB2400060 | Supplement | 2024/03/20 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG | CDE ↗ |
| JYSB2300096 | Supplement | 2023/05/23 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG | CDE ↗ |
| JYSB2300095 | Supplement | 2023/05/23 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG | CDE ↗ |
| JYSB2200195 | Supplement | 2022/10/11 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG | CDE ↗ |
| JYSB2200194 | Supplement | 2022/10/11 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG | CDE ↗ |
| JYSB2200035 | Supplement | 2022/03/03 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG | CDE ↗ |
| JYSB2200034 | Supplement | 2022/03/03 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG | CDE ↗ |
Montelukast Sodium Chewable Tablets 10 records · Latest accepted 2025/05/28
Supplement · 6Import re-registration · 4
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHB2500293 | Supplement | 2025/05/28 | N.V. Organon; Organon Pharma (UK) Limited | CDE ↗ |
| JYHB2500292 | Supplement | 2025/05/28 | N.V. Organon; Organon Pharma (UK) Limited | CDE ↗ |
| JYHZ2200190 | Import re-registration | 2022/07/05 | N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2200189 | Import re-registration | 2022/07/05 | N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2200188 | Import re-registration | 2022/07/05 | N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2200187 | Import re-registration | 2022/07/05 | N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHB2200252 | Supplement | 2022/05/06 | N.V. Organon; Organon Pharma (UK) Limited | CDE ↗ |
| JYHB2200251 | Supplement | 2022/05/06 | N.V. Organon; Organon Pharma (UK) Limited | CDE ↗ |
| JYHB2200250 | Supplement | 2022/05/06 | N.V. Organon; Organon Pharma (UK) Limited | CDE ↗ |
| JYHB2200249 | Supplement | 2022/05/06 | N.V. Organon; Organon Pharma (UK) Limited | CDE ↗ |
Montelukast Sodium Tablets 5 records · Latest accepted 2025/05/28
Supplement · 3Import re-registration · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHB2500291 | Supplement | 2025/05/28 | N.V. Organon; Organon Pharma (UK) Limited | CDE ↗ |
| JYHZ2200163 | Import re-registration | 2022/06/24 | N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2200162 | Import re-registration | 2022/06/24 | N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHB2200116 | Supplement | 2022/03/03 | N.V. Organon; Organon Pharma (UK) Limited | CDE ↗ |
| JYHB2200115 | Supplement | 2022/03/03 | N.V. Organon; Organon Pharma (UK) Limited | CDE ↗ |
Alendronate Sodium Tablets 5 records · Latest accepted 2025/03/12
Supplement · 3Import re-registration · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHB2500146 | Supplement | 2025/03/12 | N.V. Organon; Savio Industrial S.r.L | CDE ↗ |
| JYHZ2300138 | Import re-registration | 2023/03/17 | N.V. Organon; Savio Industrial S.r.L; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2300137 | Import re-registration | 2023/03/17 | N.V. Organon; Savio Industrial S.r.L; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHB2200120 | Supplement | 2022/03/04 | N.V. Organon; Savio Industrial S.r.L | CDE ↗ |
| JYHB2200119 | Supplement | 2022/03/04 | N.V. Organon; Savio Industrial S.r.L | CDE ↗ |
No verified English name 7 records · Latest accepted 2024/06/29
Supplement · 4Import re-registration · 3
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHB2400328 | Supplement | 2024/06/29 | N.V. Organon; Rovi Pharma Industrial Services S.A. | CDE ↗ |
| JYHZ2200240 | Import re-registration | 2022/09/01 | N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2200239 | Import re-registration | 2022/09/01 | N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2200238 | Import re-registration | 2022/09/01 | N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHB2200149 | Supplement | 2022/03/24 | N.V. Organon; Rovi Pharma Industrial Services S.A. | CDE ↗ |
| JYHB2200148 | Supplement | 2022/03/24 | N.V. Organon; Rovi Pharma Industrial Services S.A. | CDE ↗ |
| JYHB2200147 | Supplement | 2022/03/24 | N.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
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHB2400327 | Supplement | 2024/06/29 | N.V. Organon; Rovi Pharma Industrial Services S.A. | CDE ↗ |
| JYHZ2300116 | Import re-registration | 2023/03/04 | N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2300115 | Import re-registration | 2023/03/04 | N.V. Organon; Rovi Pharma Industrial Services S.A.; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHB2200179 | Supplement | 2022/04/06 | N.V. Organon; Rovi Pharma Industrial Services S.A. | CDE ↗ |
| JYHB2200178 | Supplement | 2022/04/06 | N.V. Organon; Rovi Pharma Industrial Services S.A. | CDE ↗ |
No verified English name 3 records · Latest accepted 2023/08/23
Supplement · 3
Mirtazapine Tablets 3 records · Latest accepted 2023/06/21
Import re-registration · 2Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHZ2300265 | Import re-registration | 2023/06/21 | N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2300264 | Import re-registration | 2023/06/21 | N.V. Organon; Organon Pharma (UK) Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHB2200042 | Supplement | 2022/01/21 | N.V. Organon; Merck Sharp & Dohme Ltd. | CDE ↗ |
No verified English name 2 records · Latest accepted 2023/02/11
Import re-registration · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHZ2300061 | Import re-registration | 2023/02/11 | N.V. Organon; Anesta LLC; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| JYHZ2300060 | Import re-registration | 2023/02/11 | N.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
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JTS2100511 | Not stated by source | 2021/08/19 | N.V. Organon; Hangzhou Mo Sha Dong Pharmaceutical Co., Ltd. romanized | CDE ↗ |
No verified English name 1 records · Latest accepted 2021/08/19
Not stated by source · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JTS2100512 | Not stated by source | 2021/08/19 | N.V. Organon; Hangzhou Mo Sha Dong Pharmaceutical Co., Ltd. romanized | CDE ↗ |
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
- 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 ↗ - 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 ↗ - 2026/10/10Accepted
Etoricoxib Tablets
JYHZ2600262
Fact date: 2026/10/10 · Site observation date: 2026/10/22
View source ↗ - 2026/10/10Accepted
Etoricoxib Tablets
JYHZ2600261
Fact date: 2026/10/10 · Site observation date: 2026/10/22
View source ↗ - 2026/10/10Accepted
Etoricoxib Tablets
JYHZ2600260
Fact date: 2026/10/10 · Site observation date: 2026/10/22
View source ↗ - 2026/10/10Accepted
Etoricoxib Tablets
JYHZ2600259
Fact date: 2026/10/10 · Site observation date: 2026/10/22
View source ↗ - 2026/10/10Accepted
Etoricoxib Tablets
JYHZ2600258
Fact date: 2026/10/10 · Site observation date: 2026/10/22
View source ↗ - 2026/10/10Accepted
Etoricoxib Tablets
JYHZ2600257
Fact date: 2026/10/10 · Site observation date: 2026/10/22
View source ↗ - 2026/10/10Accepted
Etoricoxib Tablets
JYHZ2600256
Fact date: 2026/10/10 · Site observation date: 2026/10/22
View source ↗ - 2026/10/10Accepted
Etoricoxib Tablets
JYHZ2600255
Fact date: 2026/10/10 · Site observation date: 2026/10/22
View source ↗ - 2026/09/21Accepted
Simvastatin Tablets
JYHZ2600230
Fact date: 2026/09/21 · Site observation date: 2026/10/22
View source ↗ - 2026/09/21Accepted
Simvastatin Tablets
JYHZ2600229
Fact date: 2026/09/21 · Site observation date: 2026/10/22
View source ↗ - 2026/09/16Accepted
Ganirelix Injection
JYHB2600523
Fact date: 2026/09/16 · Site observation date: 2026/10/22
View source ↗ - 2026/09/16Accepted
Ezetimibe and Simvastatin Tablets
JYHB2600521
Fact date: 2026/09/16 · Site observation date: 2026/10/22
View source ↗ - 2026/09/16Accepted
Ezetimibe and Simvastatin Tablets
JYHB2600520
Fact date: 2026/09/16 · Site observation date: 2026/10/22
View source ↗ - 2026/09/10Accepted
No verified English name
JTS2600142
Fact date: 2026/09/10 · Site observation date: 2026/10/22
View source ↗ - 2026/08/27Accepted
No verified English name
JYHB2600494
Fact date: 2026/08/27 · Site observation date: 2026/10/22
View source ↗ - 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.
| Drug | Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|---|
| Etoricoxib Tablets | JYHZ2600262 | Import re-registration | 2026/10/10 | N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| Etoricoxib Tablets | JYHZ2600261 | Import re-registration | 2026/10/10 | N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| Etoricoxib Tablets | JYHZ2600260 | Import re-registration | 2026/10/10 | N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| Etoricoxib Tablets | JYHZ2600259 | Import re-registration | 2026/10/10 | N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| Etoricoxib Tablets | JYHZ2600258 | Import re-registration | 2026/10/10 | N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| Etoricoxib Tablets | JYHZ2600257 | Import re-registration | 2026/10/10 | N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| Etoricoxib Tablets | JYHZ2600256 | Import re-registration | 2026/10/10 | N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| Etoricoxib Tablets | JYHZ2600255 | Import re-registration | 2026/10/10 | N. V. Organon; Rovi Pharma Industrial Services S.A; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| Simvastatin Tablets | JYHZ2600230 | Import re-registration | 2026/09/21 | N.V. Organon; Organon Pharma (UK)Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| Simvastatin Tablets | JYHZ2600229 | Import re-registration | 2026/09/21 | N.V. Organon; Organon Pharma (UK)Limited; Organon (Shanghai) Pharmaceutical Technology Co. Ltd. | CDE ↗ |
| Ganirelix Injection | JYHB2600523 | Supplement | 2026/09/16 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG | CDE ↗ |
| Ezetimibe and Simvastatin Tablets | JYHB2600521 | Supplement | 2026/09/16 | N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH); Organon Pharma (UK) Limited | CDE ↗ |
| Ezetimibe and Simvastatin Tablets | JYHB2600520 | Supplement | 2026/09/16 | N.V. Organon; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH); Organon Pharma (UK) Limited | CDE ↗ |
| No verified English name | JYHB2600494 | Supplement | 2026/08/27 | N.V. Organon; Name not romanized; Name not romanized | CDE ↗ |
| No verified English name | JYHB2600493 | Supplement | 2026/08/27 | N.V. Organon; Name not romanized; Name not romanized | CDE ↗ |
| No verified English name | JYSB2500134 | Supplement | 2025/06/14 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG | CDE ↗ |
| No verified English name | JYSB2500133 | Supplement | 2025/06/14 | N.V. Organon; Vetter Pharma-Fertigung GmbH & Co. KG | CDE ↗ |
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.
| Drug | Marketing authorization holder | Manufacturer | Approval number | Approved | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| No verified English name | N.V. Organon | Anesta LLC | H20160677; H20160688 | 2011/08/25 | Imported originator drug | CDE ↗ |
| No verified English name | N.V. Organon | Anesta LLC | H20160676 | 2011/08/25 | Imported originator drug | CDE ↗ |
| Mirtazapine Tablets | N.V. Organon | N.V. Organon | H20140031;H20150540 | 2001/02/05 | Imported originator drug | CDE ↗ |
| Rocuronium Bromide Injection | N.V. Organon | Hameln Pharmaceuticals GmbH | H20140847 | 1997/01/31 | Imported originator drug | CDE ↗ |
| Tibolone Tablets | N.V.Organon | N.V.Organon | H20160575 | 1990/11/26 | Imported originator drug | CDE ↗ |
| Desogestrel and Ethinylestradiol Tablets | N.V.Organon | N.V.Organon | H20171176 | 1989/04/18 | Imported originator drug | CDE ↗ |
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.
| Name | Company / applicant | Registration number | Status | Source update date | View 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.
| Drug | Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|---|
| No verified English name | JTH2600204 | Not stated by source | 2026/09/23 | Aspen Oss BV; N.V. Organon; Ou Jia Long (Shanghai) Pharmaceuticals Trading Co., Ltd. romanized | CDE ↗ |
| No verified English name | JTH2600203 | Not stated by source | 2026/09/23 | Aspen Oss BV; N.V. Organon; Ou Jia Long (Shanghai) Pharmaceuticals Trading Co., Ltd. romanized | CDE ↗ |
| Sugammadex Sodium Injection | JYHB2600367 | Supplement | 2026/07/02 | Merck Sharp & Dohme B.V.; N.V. Organon | CDE ↗ |
| Posaconazole Enteric-coated Tablets | JYHB2500399 | Supplement | 2025/08/02 | Merck Sharp & Dohme B.V.; N.V. Organon | CDE ↗ |
| Posaconazole Enteric-coated Tablets | JYHB2400433 | Supplement | 2024/08/07 | Merck Sharp & Dohme B.V.; N.V. Organon | CDE ↗ |
| Posaconazole Enteric-coated Tablets | JYHB2400381 | Supplement | 2024/07/23 | Merck Sharp & Dohme B.V.; N.V. Organon | CDE ↗ |
| Posaconazole Enteric-coated Tablets | JYHB2300729 | Supplement | 2023/12/16 | Merck Sharp & Dohme B.V.; N.V. Organon | CDE ↗ |
| Posaconazole Enteric-coated Tablets | JYHZ2300099 | Import re-registration | 2023/02/23 | Merck Sharp & Dohme B.V.; N.V. Organon; Name not romanized | CDE ↗ |
| Posaconazole Enteric-coated Tablets | JYHB2200482 | Supplement | 2022/09/04 | Merck Sharp & Dohme B.V.; N.V.Organon | CDE ↗ |
| Posaconazole Enteric-coated Tablets | JYHB2200261 | Supplement | 2022/05/11 | Merck Sharp & Dohme B.V.; N.V.Organon | CDE ↗ |
| Posaconazole Enteric-coated Tablets | JYHB2100138 | Supplement | 2021/02/11 | Merck Sharp & Dohme B.V.; N.V.Organon | CDE ↗ |
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.