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Matched- Active ingredients (original)
- TRAZODONE HYDROCHLORIDE
- Dosage form (original)
- TABLET
- 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 approvalApproved before 1982
ANDA applications33
RLD applicantPRAGMA PHARMACEUTICALS LLC
Currently marketed products: 42 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A070491-001 | TRAZODONE HYDROCHLORIDE | USL PHARMA INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG | 1987/04/29 | N / N | DISCONTINUED | openFDA ↗ |
| A070492-001 | TRAZODONE HYDROCHLORIDE | USL PHARMA INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG | 1987/04/29 | N / N | DISCONTINUED | openFDA ↗ |
| A070857-001 | TRAZODONE HYDROCHLORIDE | WATSON LABORATORIES INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG | 1986/10/10 | N / N | DISCONTINUED | openFDA ↗ |
| A070858-001 | TRAZODONE HYDROCHLORIDE | WATSON LABORATORIES INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG | 1986/10/10 | N / N | DISCONTINUED | openFDA ↗ |
| A070921-001 | TRAZODONE HYDROCHLORIDE | QUANTUM PHARMICS LTD | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG | 1986/12/01 | N / N | DISCONTINUED | openFDA ↗ |
| A070942-001 | TRIALODINE | QUANTUM PHARMICS LTD | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG | 1986/12/01 | N / N | DISCONTINUED | openFDA ↗ |
| A071112-001 | TRAZODONE HYDROCHLORIDE | WATSON LABORATORIES INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG | 1986/11/17 | N / N | DISCONTINUED | openFDA ↗ |
| A071113-001 | TRAZODONE HYDROCHLORIDE | WATSON LABORATORIES INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG | 1986/11/17 | N / N | DISCONTINUED | openFDA ↗ |
| A071139-001 | TRAZODONE HYDROCHLORIDE | AMERICAN THERAPEUTICS INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG | 1986/10/29 | N / N | DISCONTINUED | openFDA ↗ |
| A071140-001 | TRAZODONE HYDROCHLORIDE | AMERICAN THERAPEUTICS INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG | 1986/10/29 | N / N | DISCONTINUED | openFDA ↗ |
| A071196-001 | TRAZODONE HYDROCHLORIDE | APOTEX INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG | 1987/03/25 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A071196-002 | TRAZODONE HYDROCHLORIDE | APOTEX INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 150MG | 1999/04/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A071196-003 | TRAZODONE HYDROCHLORIDE | APOTEX INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 300MG | 1999/04/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A071258-001 | TRAZODONE HYDROCHLORIDE | APOTEX INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG | 1987/03/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A071405-001 | TRAZODONE HYDROCHLORIDE | NATCO PHARMA LTD | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG | 1991/02/27 | N / N | DISCONTINUED | openFDA ↗ |
| A071406-001 | TRAZODONE HYDROCHLORIDE | NATCO PHARMA LTD | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG | 1991/02/27 | N / N | DISCONTINUED | openFDA ↗ |
| A071514-001 | TRAZODONE HYDROCHLORIDE | ALVOGEN INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG | 1988/04/18 | N / N | DISCONTINUED | openFDA ↗ |
| A071523-001 | TRAZODONE HYDROCHLORIDE | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG | 1987/12/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A071524-001 | TRAZODONE HYDROCHLORIDE | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG | 1987/12/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A071525-001 | TRAZODONE HYDROCHLORIDE | PLIVA INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 150MG | 1988/03/09 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A071636-001 | TRAZODONE HYDROCHLORIDE | ALVOGEN INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG | 1988/04/18 | N / N | DISCONTINUED | openFDA ↗ |
| A072192-001 | TRAZODONE HYDROCHLORIDE | OXFORD PHARMACEUTICALS LLC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG | 1989/02/02 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A072193-001 | TRAZODONE HYDROCHLORIDE | OXFORD PHARMACEUTICALS LLC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG | 1989/02/02 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A072193-002 | TRAZODONE HYDROCHLORIDE | OXFORD PHARMACEUTICALS LLC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 25MG | 2026/09/01 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A072193-003 | TRAZODONE HYDROCHLORIDE | OXFORD PHARMACEUTICALS LLC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 75MG | 2026/09/01 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A072483-001 | TRAZODONE HYDROCHLORIDE | AIPING PHARMACEUTICAL INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG | 1990/04/30 | N / N | DISCONTINUED | openFDA ↗ |
| A072484-001 | TRAZODONE HYDROCHLORIDE | RISING PHARMA HOLDINGS INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG | 1990/04/30 | N / N | DISCONTINUED | openFDA ↗ |
| A073137-001 | TRAZODONE HYDROCHLORIDE | SUN PHARMACEUTICAL INDUSTRIES INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG | 1993/03/24 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A073137-002 | TRAZODONE HYDROCHLORIDE | SUN PHARMACEUTICAL INDUSTRIES INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG | 1993/03/24 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A073137-003 | TRAZODONE HYDROCHLORIDE | SUN PHARMACEUTICAL INDUSTRIES INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 150MG | 1995/12/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A074357-001 | TRAZODONE HYDROCHLORIDE | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 150MG | 1997/04/30 | N / N | DISCONTINUED | openFDA ↗ |
| A090514-001 | TRAZODONE HYDROCHLORIDE | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG | 2009/06/02 | N / N | DISCONTINUED | openFDA ↗ |
| A090514-002 | TRAZODONE HYDROCHLORIDE | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG | 2009/06/02 | N / N | DISCONTINUED | openFDA ↗ |
| A090514-003 | TRAZODONE HYDROCHLORIDE | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 150MG | 2009/06/02 | N / N | DISCONTINUED | openFDA ↗ |
| A090514-004 | TRAZODONE HYDROCHLORIDE | PHARMOBEDIENT CONSULTING LLC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 300MG | 2009/06/02 | N / N | DISCONTINUED | openFDA ↗ |
| A202180-001 | TRAZODONE HYDROCHLORIDE | TORRENT PHARMACEUTICALS LTD | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG | 2013/11/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202180-002 | TRAZODONE HYDROCHLORIDE | TORRENT PHARMACEUTICALS LTD | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG | 2013/11/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202180-003 | TRAZODONE HYDROCHLORIDE | TORRENT PHARMACEUTICALS LTD | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 150MG | 2013/11/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202180-004 | TRAZODONE HYDROCHLORIDE | TORRENT PHARMACEUTICALS LTD | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 300MG | 2013/11/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204852-001 | TRAZODONE HYDROCHLORIDE | AUROBINDO PHARMA LTD | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG | 2020/02/05 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204852-002 | TRAZODONE HYDROCHLORIDE | AUROBINDO PHARMA LTD | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG | 2020/02/05 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204852-003 | TRAZODONE HYDROCHLORIDE | AUROBINDO PHARMA LTD | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 150MG | 2020/02/05 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204852-004 | TRAZODONE HYDROCHLORIDE | AUROBINDO PHARMA LTD | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 300MG | 2020/02/05 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205253-001 | TRAZODONE HYDROCHLORIDE | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG | 2017/10/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205253-002 | TRAZODONE HYDROCHLORIDE | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG | 2017/10/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205253-003 | TRAZODONE HYDROCHLORIDE | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 150MG | 2017/10/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205253-004 | TRAZODONE HYDROCHLORIDE | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 300MG | 2017/10/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A206923-001 | TRAZODONE HYDROCHLORIDE | ACCORD HEALTHCARE INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG | 2017/09/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A206923-002 | TRAZODONE HYDROCHLORIDE | ACCORD HEALTHCARE INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG | 2017/09/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A206923-003 | TRAZODONE HYDROCHLORIDE | ACCORD HEALTHCARE INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 150MG | 2017/09/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A206923-004 | TRAZODONE HYDROCHLORIDE | ACCORD HEALTHCARE INC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 300MG | 2017/09/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211116-001 | TRAZODONE HYDROCHLORIDE | CROSSMEDIKA SA | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG | 2024/05/20 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211116-002 | TRAZODONE HYDROCHLORIDE | CROSSMEDIKA SA | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG | 2024/05/20 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211116-003 | TRAZODONE HYDROCHLORIDE | CROSSMEDIKA SA | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 150MG | 2024/05/20 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211116-004 | TRAZODONE HYDROCHLORIDE | CROSSMEDIKA SA | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 300MG | 2024/05/20 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217740-001 | TRAZODONE HYDROCHLORIDE | GRAVITI PHARMACEUTICALS PRIVATE LTD | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG | 2024/08/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217740-002 | TRAZODONE HYDROCHLORIDE | GRAVITI PHARMACEUTICALS PRIVATE LTD | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG | 2024/08/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217740-003 | TRAZODONE HYDROCHLORIDE | GRAVITI PHARMACEUTICALS PRIVATE LTD | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 150MG | 2024/08/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A217740-004 | TRAZODONE HYDROCHLORIDE | GRAVITI PHARMACEUTICALS PRIVATE LTD | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 300MG | 2024/08/27 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218988-001 | TRAZODONE HYDROCHLORIDE | GRANULES INDIA LTD | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG | 2024/08/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218988-002 | TRAZODONE HYDROCHLORIDE | GRANULES INDIA LTD | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG | 2024/08/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218988-003 | TRAZODONE HYDROCHLORIDE | GRANULES INDIA LTD | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 150MG | 2024/08/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218988-004 | TRAZODONE HYDROCHLORIDE | GRANULES INDIA LTD | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 300MG | 2024/08/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N018207-001 | DESYREL | PRAGMA PHARMACEUTICALS LLC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Approved before 1982 | Y / N | DISCONTINUED | openFDA ↗ |
| N018207-002 | DESYREL | PRAGMA PHARMACEUTICALS LLC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Approved before 1982 | Y / N | DISCONTINUED | openFDA ↗ |
| N018207-003 | DESYREL | PRAGMA PHARMACEUTICALS LLC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1985/03/25 | Y / N | DISCONTINUED | openFDA ↗ |
| N018207-004 | DESYREL | PRAGMA PHARMACEUTICALS LLC | TABLET | ORAL | TRAZODONE HYDROCHLORIDE: 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1988/11/07 | 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 expiration2029/03/13
Substance patent expiration (DS flag)2029/03/13
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 |
|---|---|---|---|---|---|---|
| N018207-001 | 8133893 | 2029/03/13 | Y / Y | — | — | openFDA ↗ |
| N018207-002 | 8133893 | 2029/03/13 | Y / Y | — | — | openFDA ↗ |
| N018207-003 | 8133893 | 2029/03/13 | Y / Y | — | — | openFDA ↗ |
| N018207-004 | 8133893 | 2029/03/13 | Y / Y | — | — | openFDA ↗ |
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 21
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | 国药准字H2026609350mg | 2026/09/22 | Official source ↗ |
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | 国药准字H2026609425mg | 2026/09/22 | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H2026585025mg | 2026/09/02 | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H2026584950mg | 2026/09/02 | Official source ↗ |
| Anhui Wan Bang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H2026494250mg | 2026/06/23 | Official source ↗ |
| Fujian Dong Rui Pharmaceutical Co., Ltd. romanized | 国药准字H2026457150mg | 2026/05/27 | Official source ↗ |
| Fujian Dong Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20264572100mg | 2026/05/27 | Official source ↗ |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H2026422825mg | 2026/05/07 | Official source ↗ |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H2026422750mg | 2026/05/07 | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H2026324725mg | 2026/01/27 | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H2026324650mg | 2026/01/27 | Official source ↗ |
| Zhejiang Jiang Bei Pharma Co., Ltd. romanized | 国药准字H2026315250mg | 2026/01/20 | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H2026307550mg | 2026/01/14 | Official source ↗ |
| Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized | 国药准字H2025626750mg | 2025/12/16 | Official source ↗ |
| Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized | 国药准字H2025626625mg | 2025/12/16 | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | 2025/12/16 | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20256259100mg | 2025/12/16 | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | 国药准字H2025625850mg | 2025/12/16 | Official source ↗ |
| Hua Yi Tai Kang Pharma Co., Ltd. romanized | 国药准字H2025613825mg | 2025/12/03 | Official source ↗ |
| Hua Yi Tai Kang Pharma Co., Ltd. romanized | 国药准字H2025613750mg | 2025/12/03 | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H2025604250mg | 2025/11/25 | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H2025574650mg | 2025/10/21 | Official source ↗ |
| Shenyang Fu Ning Pharma Co., Ltd. romanized | 国药准字H2005022350mg | 2025/08/18 | Official source ↗ |
| Hebei Long Hai Pharma Co., Ltd. romanized | 国药准字H2025485950mg | 2025/07/15 | Official source ↗ |
| Xian Yuan Da Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H2025473550mg | 2025/06/30 | Official source ↗ |
| Jiangxi Ke Rui Pharma Co., Ltd. romanized | 国药准字H2025473850mg | 2025/06/30 | Official source ↗ |
| Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized | 国药准字H2025445850mg | 2025/06/03 | Official source ↗ |
| Chongqing Hai Mo Ni Pharmaceutical Co., Ltd. romanized | 国药准字H2026352650mg | 2026/03/10 | Official source ↗ |
| Yuan Da Pharmaceuticals (Xian) Co., Ltd. romanized | 国药准字H2026918625mg | 2026/07/31 | Official source ↗ |
NHSA approval numbers 36
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Foyou Pharma CO.,LTD | 国药准字H2026307550mg | — | Official source ↗ |
| Shenyang Hua Tai Drug Research Co., Ltd. romanized | 国药准字H20133205100mg | — | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H2025604250mg | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H2026324725mg | — | Official source ↗ |
| Shandong Xin Yi Pharmaceutical Co., Ltd. romanized | 国药准字H2025485950mg | — | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | 国药准字H2025625850mg | — | Official source ↗ |
| Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized | 国药准字H2025626625mg | — | Official source ↗ |
| Fujian Dong Rui Pharmaceutical Co., Ltd. romanized | 国药准字H2026457150mg | — | Official source ↗ |
| Hua Yi Tai Kang Pharma Co., Ltd. romanized | 国药准字H2025613825mg | — | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H2025574650mg | — | Official source ↗ |
| Taiwan Hai Mo Ni Pharma Co., Ltd. romanized | 国药准字J20190011See source | — | Official source ↗ |
| Taiwan Hai Mo Ni Pharma Co., Ltd. romanized | HC20171014See source | — | Official source ↗ |
| Zhejiang Jiang Bei Pharma Co., Ltd. romanized | 国药准字H2026315250mg | — | Official source ↗ |
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | 国药准字H2026609350mg | — | Official source ↗ |
| Taiwan Hai Mo Ni Pharma Co., Ltd. romanized | 国药准字HC20191000See source | — | Official source ↗ |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H2026422825mg | — | Official source ↗ |
| Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized | 国药准字H2025445850mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Yuan Da Pharmaceuticals (Xian) Co., Ltd. romanized | 国药准字H2025473550mg | — | Official source ↗ |
| Jiangxi Ke Rui Pharma Co., Ltd. romanized | 国药准字H2025473850mg | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H2026307550mg | — | Official source ↗ |
| Shenyang Hua Tai Drug Research Co., Ltd. romanized | 国药准字H20133205100mg | — | Official source ↗ |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H2025604250mg | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H2026324725mg | — | Official source ↗ |
| Fujian Dong Rui Pharmaceutical Co., Ltd. romanized | 国药准字H2026457150mg | — | Official source ↗ |
| Hua Yi Tai Kang Pharma Co., Ltd. romanized | 国药准字H2025613825mg | — | Official source ↗ |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H2025574650mg | — | Official source ↗ |
| Taiwan Hai Mo Ni Pharma Co., Ltd. romanized | 国药准字J20190011See source | — | Official source ↗ |
| Taiwan Hai Mo Ni Pharma Co., Ltd. romanized | 国药准字HC20171014See source | — | Official source ↗ |
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | 国药准字H2026609350mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Jiangxi Ke Rui Pharma Co., Ltd. romanized | 国药准字H2025473850mg | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H2026307550mg | — | Official source ↗ |
| Fujian Dong Rui Pharmaceutical Co., Ltd. romanized | 国药准字H2026457150mg | — | Official source ↗ |
| Hua Yi Tai Kang Pharma Co., Ltd. romanized | 国药准字H2025613825mg | — | Official source ↗ |
| Chongqing Hai Mo Ni Pharmaceutical Co., Ltd. romanized | 国药准字H2026352650mg | — | Official source ↗ |
| Taiwan Hai Mo Ni Pharma Co., Ltd. romanized | 国药准字HC20171014See source | — | Official source ↗ |
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | 国药准字H2026609350mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Changzhou Hua Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2002035550mg | — | Official source ↗ |
| Chongqing Hai Mo Ni Pharmaceutical Co., Ltd. romanized | 国药准字H2026352650mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Changzhou Hua Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2002035550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Changzhou Hua Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H2002035550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H2025626550mg | — | Official source ↗ |
| Shenyang Hua Tai Drug Research Co., Ltd. romanized | 国药准字H2006003725mg | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H2026324650mg | — | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20256259100mg | — | Official source ↗ |
| Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized | 国药准字H2025626750mg | — | Official source ↗ |
| Fujian Dong Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20264572100mg | — | Official source ↗ |
| Hua Yi Tai Kang Pharma Co., Ltd. romanized | 国药准字H2025613750mg | — | Official source ↗ |
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | 国药准字H2026609425mg | — | Official source ↗ |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H2026422750mg | — | Official source ↗ |
| Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized | 国药准字H20254459100mg | — | Official source ↗ |
| Shenyang Hua Tai Drug Research Co., Ltd. romanized | 国药准字H2006003725mg | — | Official source ↗ |
| Fujian Dong Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20264572100mg | — | Official source ↗ |
| Hua Yi Tai Kang Pharma Co., Ltd. romanized | 国药准字H2025613750mg | — | Official source ↗ |
| Taiwan Hai Mo Ni Pharma Co., Ltd. romanized | 国药准字HC20171014See source | — | Official source ↗ |
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | 国药准字H2026609425mg | — | Official source ↗ |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H2026422750mg | — | Official source ↗ |
| Fujian Dong Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20264572100mg | — | Official source ↗ |
| Hua Yi Tai Kang Pharma Co., Ltd. romanized | 国药准字H2025613750mg | — | Official source ↗ |
| Hefei Ying Tai Pharmaceutical Co., Ltd. romanized | 国药准字H2026609425mg | — | Official source ↗ |
| Shenyang Hua Tai Drug Research Co., Ltd. romanized | 国药准字H2005022350mg | — | Official source ↗ |
| Shenyang Hua Tai Drug Research Co., Ltd. romanized | 国药准字H2005022350mg | — | Official source ↗ |
| Shenyang Hua Tai Drug Research Co., Ltd. romanized | 国药准字H2005022350mg | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H2026584950mg | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H2026628450mg | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H2026584950mg | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H2026628450mg | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H2026584950mg | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H2026628450mg | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H2026584950mg | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H2026628450mg | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H2026584950mg | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H2026628450mg | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H2026584950mg | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H2026584950mg | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H2026584950mg | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H2026585025mg | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H2026585025mg | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H2026585025mg | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H2026585025mg | — | Official source ↗ |
Under review 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHS2600647 | 2026/03/12 | Official source ↗ |
| Lotus Pharmaceutical Co. Ltd. Nantou Plant; Chongqing Hemony Pharmaceutical Co. Ltd | JYHB2650002 | 2026/09/01 | Official source ↗ |
| Lotus Pharmaceutical Co. Ltd. Nantou Plant | JYHB2650001 | 2026/09/01 | Official source ↗ |
| Shenyang Hua Tai Drug Research Co., Ltd. romanized; Shenyang Fu Ning Pharma Co., Ltd. romanized | CYHB2601501 | 2026/08/05 | Official source ↗ |
| San Jin Group Hunan San Jin Pharmaceutical Co., Ltd. romanized | CYHS2600911 | 2026/04/21 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHS2600647 | 2026/03/12 | Official source ↗ |
| San Jin Group Hunan San Jin Pharmaceutical Co., Ltd. romanized | CYHS2600911 | 2026/04/21 | Official source ↗ |
API companies with A status 8
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Sichuan Ren An Pharma Co., Ltd. romanized | Y20240000132 | 2026/09/12 | Official source ↗ |
| Hunan Jiu Dian Hong Yang Pharmaceutical Co., Ltd. romanized | Y20230001003 | 2026/06/02 | Official source ↗ |
| Medilux Laboratories Pvt. Ltd. | Y20220000900 | 2026/09/16 | Official source ↗ |
| AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO ACRAF SPA | Y20220000333 | 2025/09/15 | Official source ↗ |
| Matrix Pharmacorp Private Limited | Y20210000921 | 2026/09/16 | Official source ↗ |
| Piramal Pharma Limited | Y20210000635 | 2023/08/14 | Official source ↗ |
| Changzhou Hua Sheng Pharmaceutical Co., Ltd. romanized | Y20190004670 | 2025/07/24 | Official source ↗ |
| Shenyang Fu Ning Pharma Co., Ltd. romanized | Y20190002723 | 2024/07/03 | 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 ↗ · 10-194 · 2022/10/11
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