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Sign in to subscribeIsosorbide Mononitrate Extended-Release Tablets
Matched- Active ingredients (original)
- ISOSORBIDE MONONITRATE
- Dosage form (original)
- TABLET, EXTENDED RELEASE
- Route (original)
- ORAL
Read these limits
- US patent expiration does not establish Chinese patent expiration. Dates here come from the US Orange Book; Chinese patent status needs separate checking.
- The Orange Book lists holder-submitted patents and does not cover all related patents.
- “Unmatched” means no English ingredient-name counterpart in the Chinese official-name sources loaded here; it does not mean no Chinese approval or filing. A zero count means a Chinese name is matched but no records were found in the loaded source. Source dates appear below.
- This page contains no sales or market-size data and cannot establish development value.
- Names on unmatched rows are the original FDA Orange Book names, without Chinese translation. The same ingredient may have a different generic name in China.
US-approved products
Application numbers, product numbers and original fields are retained. Marketing status is shown as listed in the source.
Earliest approval1993/08/12
ANDA applications17
RLD applicantSCHERING PLOUGH CORP
Currently marketed products: 21 · Counts FDA prescription and OTC marketing categories as listed; discontinued or unknown categories are excluded.
| Application / product number | Brand name (original) | Applicant (original) | Dosage form (original) | Route (original) | Strength (original) | Earliest approval | RLD / RS | Marketing status (original) | Official source |
|---|---|---|---|---|---|---|---|---|---|
| A075041-001 | ISOSORBIDE MONONITRATE | ALKERMES GAINESVILLE LLC | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 60MG | 1998/09/22 | N / N | DISCONTINUED | openFDA ↗ |
| A075155-001 | ISOSORBIDE MONONITRATE | CHARTWELL MOLECULAR HOLDINGS LLC | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 60MG | 1998/10/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A075155-002 | ISOSORBIDE MONONITRATE | CHARTWELL MOLECULAR HOLDINGS LLC | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 30MG | 2000/01/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A075155-003 | ISOSORBIDE MONONITRATE | CHARTWELL MOLECULAR HOLDINGS LLC | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 120MG | 2000/08/04 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A075166-001 | ISOSORBIDE MONONITRATE | SKYEPHARMA AG | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 60MG | 1999/10/07 | N / N | DISCONTINUED | openFDA ↗ |
| A075306-001 | ISOSORBIDE MONONITRATE | ACTAVIS ELIZABETH LLC | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 30MG | 1998/12/31 | N / N | DISCONTINUED | openFDA ↗ |
| A075306-002 | ISOSORBIDE MONONITRATE | ACTAVIS ELIZABETH LLC | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 60MG | 1998/12/31 | N / N | DISCONTINUED | openFDA ↗ |
| A075395-001 | ISOSORBIDE MONONITRATE | ZYDUS HEALTHCARE USA LLC | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 30MG | 2000/03/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A075395-002 | ISOSORBIDE MONONITRATE | ZYDUS HEALTHCARE USA LLC | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 60MG | 2000/03/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A075395-003 | ISOSORBIDE MONONITRATE | ZYDUS HEALTHCARE USA LLC | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 120MG | 2000/03/16 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A075448-001 | ISOSORBIDE MONONITRATE | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 60MG | 2000/06/19 | N / N | DISCONTINUED | openFDA ↗ |
| A075448-002 | ISOSORBIDE MONONITRATE | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 30MG | 2001/08/07 | N / N | DISCONTINUED | openFDA ↗ |
| A075448-003 | ISOSORBIDE MONONITRATE | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 120MG | 2001/08/07 | N / N | DISCONTINUED | openFDA ↗ |
| A075522-001 | ISOSORBIDE MONONITRATE | DEXCEL LTD | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 60MG | 2000/04/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A075522-002 | ISOSORBIDE MONONITRATE | DEXCEL LTD | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 30MG | 2016/09/20 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A076813-001 | ISOSORBIDE MONONITRATE | HIKMA PHARMACEUTICALS USA INC | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 60MG | 2005/01/07 | N / N | DISCONTINUED | openFDA ↗ |
| A076813-002 | ISOSORBIDE MONONITRATE | HIKMA PHARMACEUTICALS USA INC | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 30MG | 2006/03/30 | N / N | DISCONTINUED | openFDA ↗ |
| A090598-001 | ISOSORBIDE MONONITRATE | STRIDES PHARMA INTERNATIONAL AG | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 30MG | 2010/08/11 | N / N | DISCONTINUED | openFDA ↗ |
| A090598-002 | ISOSORBIDE MONONITRATE | STRIDES PHARMA INTERNATIONAL AG | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 60MG | 2010/08/11 | N / N | DISCONTINUED | openFDA ↗ |
| A090598-003 | ISOSORBIDE MONONITRATE | STRIDES PHARMA INTERNATIONAL AG | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 120MG | 2010/08/11 | N / N | DISCONTINUED | openFDA ↗ |
| A200270-001 | ISOSORBIDE MONONITRATE | TORRENT PHARMACEUTICALS LTD | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 30MG | 2011/06/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A200495-001 | ISOSORBIDE MONONITRATE | TORRENT PHARMACEUTICALS LTD | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 60MG | 2011/06/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A200495-002 | ISOSORBIDE MONONITRATE | TORRENT PHARMACEUTICALS LTD | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 120MG | 2011/06/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A209684-001 | ISOSORBIDE MONONITRATE | ACCORD HEALTHCARE INC | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 30MG | 2017/10/24 | N / N | DISCONTINUED | openFDA ↗ |
| A209684-002 | ISOSORBIDE MONONITRATE | ACCORD HEALTHCARE INC | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 60MG | 2017/10/24 | N / N | DISCONTINUED | openFDA ↗ |
| A209684-003 | ISOSORBIDE MONONITRATE | ACCORD HEALTHCARE INC | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 120MG | 2017/10/24 | N / N | DISCONTINUED | openFDA ↗ |
| A210822-001 | ISOSORBIDE MONONITRATE | DEXCEL LTD | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 120MG | 2018/08/29 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210918-001 | ISOSORBIDE MONONITRATE | RICONPHARMA LLC | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 30MG | 2018/11/05 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210918-002 | ISOSORBIDE MONONITRATE | RICONPHARMA LLC | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 60MG | 2018/11/05 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210918-003 | ISOSORBIDE MONONITRATE | RICONPHARMA LLC | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 120MG | 2018/11/05 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214115-001 | ISOSORBIDE MONONITRATE | SHANDONG NEW TIME PHARMACEUTICAL CO LTD | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 120MG | 2022/04/29 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214115-002 | ISOSORBIDE MONONITRATE | SHANDONG NEW TIME PHARMACEUTICAL CO LTD | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 30MG | 2024/02/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214115-003 | ISOSORBIDE MONONITRATE | SHANDONG NEW TIME PHARMACEUTICAL CO LTD | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 60MG | 2024/02/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216557-001 | ISOSORBIDE MONONITRATE | AUROBINDO PHARMA LTD | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 30MG | 2022/11/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216557-002 | ISOSORBIDE MONONITRATE | AUROBINDO PHARMA LTD | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 60MG | 2022/11/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A216557-003 | ISOSORBIDE MONONITRATE | AUROBINDO PHARMA LTD | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 120MG | 2022/11/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218255-001 | ISOSORBIDE MONONITRATE | ZYDUS PHARMACEUTICALS USA INC | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 30MG | 2024/02/15 | N / N | DISCONTINUED | openFDA ↗ |
| A218255-002 | ISOSORBIDE MONONITRATE | ZYDUS PHARMACEUTICALS USA INC | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 60MG | 2024/02/15 | N / N | DISCONTINUED | openFDA ↗ |
| A218255-003 | ISOSORBIDE MONONITRATE | ZYDUS PHARMACEUTICALS USA INC | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 120MG | 2024/02/15 | N / N | DISCONTINUED | openFDA ↗ |
| N020225-001 | IMDUR | SCHERING PLOUGH CORP | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1993/08/12 | Y / N | DISCONTINUED | openFDA ↗ |
| N020225-002 | IMDUR | SCHERING PLOUGH CORP | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1993/08/12 | Y / N | DISCONTINUED | openFDA ↗ |
| N020225-003 | IMDUR | SCHERING PLOUGH CORP | TABLET, EXTENDED RELEASE | ORAL | ISOSORBIDE MONONITRATE: 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1995/03/30 | Y / N | DISCONTINUED | openFDA ↗ |
Listed US patents
*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.
Latest listed patent expiration—
Substance patent expiration (DS flag)—
This column includes only source rows explicitly flagged DS. A PED row without that flag is not assigned one by this site.
| Application / product number | Patent number | Listed expiration | Substance / product flags | Use code | Delisting request | Official source |
|---|---|---|---|---|---|---|
| Not listed | ||||||
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: —
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| Not listed | |||
Chinese record details
Chinese product landscape ↗The four-zero filter applies only to matched rows: catalog holders, NHSA approval numbers, applications under review, and companies filing generics this year. Unmatched rows have no Chinese counts. Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.
Catalog holders 10
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Nanjing Hua Xing Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H2026426440mg | 2026/05/07 | Official source ↗ |
| Lu Nan Pharmaceutical Group Co., Ltd. romanized | 国药准字H2024967840mg | 2024/12/06 | Official source ↗ |
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | 国药准字H2024943040mg | 2024/11/22 | Official source ↗ |
| Xizang Nuo Di Kang Technology Development Co., Ltd. romanized | 国药准字H2003041860mg | 2024/09/24 | Official source ↗ |
| Xizang Nuo Di Kang Technology Development Co., Ltd. romanized | 国药准字H2003041730mg | 2024/09/24 | Official source ↗ |
| Shandong Li Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H1999111540mg | 2022/10/14 | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H2008383840mg | 2022/07/04 | Official source ↗ |
| Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | 国药准字H1999103940mg | 2021/05/07 | Official source ↗ |
| Le Pu Pharma Co., Ltd. romanized | 国药准字H2006620340mg | 2021/02/09 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H2006671740mg | 2020/07/07 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H2006671630mg | 2020/07/07 | Official source ↗ |
| A Si Li Kang Pharmaceutical Co., Ltd. romanized | 国药准字H2003041860mg | 1999/03/17 | Official source ↗ |
| A Si Li Kang Pharmaceutical Co., Ltd. romanized | 国药准字H2003041730mg | 1999/03/17 | Official source ↗ |
NHSA approval numbers 21
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hua Run Shuang He Pharma Co., Ltd. romanized | 国药准字H1098029850mg | — | Official source ↗ |
| Shanghai Shi Kang Te Pharmaceutical Co., Ltd. romanized | 国药准字H1999030860mg | — | Official source ↗ |
| Shanghai Xin Ya Pharma Min Xing Co., Ltd. romanized | 国药准字H2001000540mg | — | Official source ↗ |
| Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 国药准字H2001064340mg | — | Official source ↗ |
| Ai Shi Jian (Guangdong) Pharmaceutical Co., Ltd. romanized | 国药准字H1098001560mg | — | Official source ↗ |
| Xizang Nuo Di Kang Technology Development Co., Ltd. romanized | 国药准字H2003041730mg | — | Official source ↗ |
| Nanjing Chen Gong Pharmaceutical Co., Ltd. romanized | 国药准字H2001024760mg | — | Official source ↗ |
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | 国药准字H2024943040mg | — | Official source ↗ |
| Le Sheng Pharma Shijiazhuang Co., Ltd. romanized | 国药准字H2002026650mg | — | Official source ↗ |
| Ya Bao Pharma Group Co., Ltd. romanized | 国药准字H2011342730mg | — | Official source ↗ |
| Le Pu Pharma Co., Ltd. romanized | 国药准字H2006620340mg | — | Official source ↗ |
| Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | 国药准字H1999103940mg | — | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H2006671630mg | — | Official source ↗ |
| Shandong Li Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H1999111540mg | — | Official source ↗ |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H2008357760mg | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H2008383840mg | — | Official source ↗ |
| Lu Nan Pharmaceutical Group Co., Ltd. romanized | 国药准字H2024967840mg | — | Official source ↗ |
| Hubei Jing Jiang Yuan Pharmaceutical Co., Ltd. romanized | 国药准字H2026426440mg | — | Official source ↗ |
| Shanghai Shi Kang Te Pharmaceutical Co., Ltd. romanized | 国药准字H1999030860mg | — | Official source ↗ |
| Shanghai Xin Ya Pharma Min Xing Co., Ltd. romanized | 国药准字H2001000540mg | — | Official source ↗ |
| Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 国药准字H2001064340mg | — | Official source ↗ |
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | 国药准字H2024943040mg | — | Official source ↗ |
| Le Sheng Pharma Shijiazhuang Co., Ltd. romanized | 国药准字H2002026650mg | — | Official source ↗ |
| Le Pu Pharma Co., Ltd. romanized | 国药准字H2006620340mg | — | Official source ↗ |
| Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | 国药准字H1999103940mg | — | Official source ↗ |
| Shandong Li Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H1999111540mg | — | Official source ↗ |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H2008357760mg | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H2008383840mg | — | Official source ↗ |
| Kunming Zhong Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20010142See source | — | Official source ↗ |
| Lu Nan Pharmaceutical Group Co., Ltd. romanized | 国药准字H2024967840mg | — | Official source ↗ |
| Hubei Jing Jiang Yuan Pharmaceutical Co., Ltd. romanized | 国药准字H2026426440mg | — | Official source ↗ |
| Shanghai Shi Kang Te Pharmaceutical Co., Ltd. romanized | 国药准字H1999030860mg | — | Official source ↗ |
| Shanghai Xin Ya Pharma Min Xing Co., Ltd. romanized | 国药准字H2001000540mg | — | Official source ↗ |
| Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 国药准字H2001064340mg | — | Official source ↗ |
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | 国药准字H2024943040mg | — | Official source ↗ |
| Le Sheng Pharma Shijiazhuang Co., Ltd. romanized | 国药准字H2002026650mg | — | Official source ↗ |
| Le Pu Pharma Co., Ltd. romanized | 国药准字H2006620340mg | — | Official source ↗ |
| Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | 国药准字H1999103940mg | — | Official source ↗ |
| Shandong Li Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H1999111540mg | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H2008383840mg | — | Official source ↗ |
| Kunming Zhong Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20010142See source | — | Official source ↗ |
| Lu Nan Pharmaceutical Group Co., Ltd. romanized | 国药准字H2024967840mg | — | Official source ↗ |
| Shanghai Shi Kang Te Pharmaceutical Co., Ltd. romanized | 国药准字H1999030860mg | — | Official source ↗ |
| Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 国药准字H2001064340mg | — | Official source ↗ |
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | 国药准字H2024943040mg | — | Official source ↗ |
| Le Pu Pharma Co., Ltd. romanized | 国药准字H2006620340mg | — | Official source ↗ |
| Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | 国药准字H1999103940mg | — | Official source ↗ |
| Shandong Li Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H1999111540mg | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H2008383840mg | — | Official source ↗ |
| Lu Nan Pharmaceutical Group Co., Ltd. romanized | 国药准字H2024967840mg | — | Official source ↗ |
| Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 国药准字H2001064340mg | — | Official source ↗ |
| Le Pu Pharma Co., Ltd. romanized | 国药准字H2006620340mg | — | Official source ↗ |
| Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | 国药准字H1999103940mg | — | Official source ↗ |
| Shandong Li Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H1999111540mg | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H2008383840mg | — | Official source ↗ |
| Lu Nan Pharmaceutical Group Co., Ltd. romanized | 国药准字H2024967840mg | — | Official source ↗ |
| Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | 国药准字H1999103940mg | — | Official source ↗ |
| Shandong Li Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H1999111540mg | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H2008383840mg | — | Official source ↗ |
| Lu Nan Pharmaceutical Group Co., Ltd. romanized | 国药准字H2024967840mg | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H2008383840mg | — | Official source ↗ |
| Lu Nan Pharmaceutical Group Co., Ltd. romanized | 国药准字H2024967840mg | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H2008383840mg | — | Official source ↗ |
| Lu Nan Pharmaceutical Group Co., Ltd. romanized | 国药准字H2024967840mg | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H2008383840mg | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H2008383840mg | — | Official source ↗ |
| Xizang Nuo Di Kang Technology Development Co., Ltd. romanized | 国药准字H2003041860mg | — | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H2006671740mg | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H2008383840mg | — | Official source ↗ |
| Kunming Zhong Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20010142See source | — | Official source ↗ |
| Xizang Nuo Di Kang Technology Development Co., Ltd. romanized | 国药准字H2003041860mg | — | Official source ↗ |
| Xizang Nuo Di Kang Technology Development Co., Ltd. romanized | 国药准字H2003041860mg | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H2008383840mg | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H2008383840mg | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H2008383840mg | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H2008383840mg | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H2008383840mg | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H2008383840mg | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H2008383840mg | — | Official source ↗ |
Under review 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shandong Bo Han Pharmaceutical Co., Ltd. romanized | CYHS2601647 | 2026/07/09 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | CYHS2601170 | 2026/05/18 | Official source ↗ |
| Zhejiang Che Tou Pharmaceutical Co., Ltd. romanized; Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized | CYHS2600668 | 2026/03/17 | Official source ↗ |
| Zhejiang Che Tou Pharmaceutical Co., Ltd. romanized; Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized | CYHS2600667 | 2026/03/17 | Official source ↗ |
| Shanghai Xin Ya Pharma Min Xing Co., Ltd. romanized | CYHB2550312 | 2025/09/03 | Official source ↗ |
Generic-filing companies this year 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shandong Bo Han Pharmaceutical Co., Ltd. romanized | CYHS2601647 | 2026/07/09 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | CYHS2601170 | 2026/05/18 | Official source ↗ |
| Zhejiang Che Tou Pharmaceutical Co., Ltd. romanized; Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized | CYHS2600668 | 2026/03/17 | Official source ↗ |
| Zhejiang Che Tou Pharmaceutical Co., Ltd. romanized; Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized | CYHS2600667 | 2026/03/17 | Official source ↗ |
API companies with A status 14
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | Y20220000036 | 2026/03/11 | Official source ↗ |
| TopRidge Pharma (Ireland) Limited | Y20190009943 | — | Official source ↗ |
| TopRidge Pharma (Ireland) Limited | Y20190009942 | — | Official source ↗ |
| Shandong Ke Yuan Pharmaceutical Co., Ltd. romanized | Y20190008394 | 2026/11/11 | Official source ↗ |
| Ji Ning Shi Rui Xin Tang Da Yu Pharma Co., Ltd. romanized | Y20190007048 | 2023/05/18 | Official source ↗ |
| Beijing Yi Min Pharma Co., Ltd. romanized | Y20190007012 | 2023/03/24 | Official source ↗ |
| Zhejiang Che Tou Pharmaceutical Co., Ltd. romanized | Y20190006904 | 2024/08/02 | Official source ↗ |
| Ren He Tang Pharma Co., Ltd. romanized | Y20190006202 | 2025/08/16 | Official source ↗ |
| Suzhou Di Wu Pharmaceutical Factory Co., Ltd. romanized | Y20190006095 | — | Official source ↗ |
| Shanghai Xin Ya Pharma Co., Ltd. romanized | Y20190004429 | — | Official source ↗ |
| Shandong Fang Ming Pharma Group Co., Ltd. romanized | Y20190004105 | 2025/04/11 | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | Y20190003467 | 2024/08/27 | Official source ↗ |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20190002360 | 2024/09/03 | Official source ↗ |
| Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | Y20190002174 | 2025/01/21 | Official source ↗ |
| Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized | Y20190001494 | 2024/12/14 | Official source ↗ |
Trial registrations 2025/2026 —
Not loaded
Sources and dates
- FDA Orange Book
- 2026/11/06
- CDE acceptance and review
- 2026/11/13 06:42
- Chemical Drug Catalog
- 2026/11/13 06:39
- API registration records
- 2026/11/13 06:41
- NHSA drug code database
- 2026/10/23
- Trial registry
- 2026/11/13 08:09 · Incomplete coverage
Chinese counts use complete ingredient, dosage-form and route matches. Unmatched and partial rows show name-source matching only and make no finding about Chinese approvals or filings. Trials cover registration-number years 2025/2026 only.
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 46-44 · 2021/10/21
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