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Matched- Active ingredients (original)
- MOXIFLOXACIN 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 approval1999/12/10
ANDA applications11
RLD applicantBAYER HEALTHCARE PHARMACEUTICALS INC
Currently marketed products: 9 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A076938-001 | MOXIFLOXACIN HYDROCHLORIDE | DR REDDYS LABORATORIES LTD | TABLET | ORAL | MOXIFLOXACIN HYDROCHLORIDE: EQ 400MG BASE | 2014/03/04 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077437-001 | MOXIFLOXACIN HYDROCHLORIDE | TEVA PHARMACEUTICALS USA | TABLET | ORAL | MOXIFLOXACIN HYDROCHLORIDE: EQ 400MG BASE | 2014/02/18 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A200160-001 | MOXIFLOXACIN HYDROCHLORIDE | TORRENT PHARMACEUTICALS LTD | TABLET | ORAL | MOXIFLOXACIN HYDROCHLORIDE: EQ 400MG BASE | 2014/04/03 | N / N | DISCONTINUED | openFDA ↗ |
| A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | AUROBINDO PHARMA LTD | TABLET | ORAL | MOXIFLOXACIN HYDROCHLORIDE: EQ 400MG BASE | 2014/03/04 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204635-001 | MOXIFLOXACIN HYDROCHLORIDE | NATCO PHARMA LTD | TABLET | ORAL | MOXIFLOXACIN HYDROCHLORIDE: EQ 400MG BASE | 2015/08/31 | N / N | DISCONTINUED | openFDA ↗ |
| A204836-001 | MOXIFLOXACIN HYDROCHLORIDE | HETERO LABS LTD UNIT V | TABLET | ORAL | MOXIFLOXACIN HYDROCHLORIDE: EQ 400MG BASE | 2023/03/02 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205348-001 | MOXIFLOXACIN HYDROCHLORIDE | CROSSMEDIKA SA | TABLET | ORAL | MOXIFLOXACIN HYDROCHLORIDE: EQ 400MG BASE | 2016/01/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A206295-001 | MOXIFLOXACIN HYDROCHLORIDE | SUNSHINE LAKE PHARMA CO LTD | TABLET | ORAL | MOXIFLOXACIN HYDROCHLORIDE: EQ 400MG BASE | 2018/09/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A207285-001 | MOXIFLOXACIN HYDROCHLORIDE | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | MOXIFLOXACIN HYDROCHLORIDE: EQ 400MG BASE | 2017/02/13 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208682-001 | MOXIFLOXACIN HYDROCHLORIDE | MSN LABORATORIES PRIVATE LTD | TABLET | ORAL | MOXIFLOXACIN HYDROCHLORIDE: EQ 400MG BASE | 2017/09/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A209143-001 | MOXIFLOXACIN HYDROCHLORIDE | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | MOXIFLOXACIN HYDROCHLORIDE: EQ 400MG BASE | 2026/03/02 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021085-001 | AVELOX | BAYER HEALTHCARE PHARMACEUTICALS INC | TABLET | ORAL | MOXIFLOXACIN HYDROCHLORIDE: EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1999/12/10 | 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 29
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Xin Tian Di Pharma Co., Ltd. romanized | 国药准字H20264303See source | 2026/05/12 | Official source ↗ |
| Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264233See source | 2026/05/07 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789See source | 2026/03/31 | Official source ↗ |
| Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20256080See source | 2025/11/25 | Official source ↗ |
| Sichuan Di Fei Te Pharma Co., Ltd. romanized | 国药准字H20255081See source | 2025/07/30 | Official source ↗ |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689See source | 2025/06/30 | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20253145See source | 2025/01/14 | Official source ↗ |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20253104See source | 2025/01/08 | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20244634See source | 2024/08/05 | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079See source | 2024/06/18 | Official source ↗ |
| Zhejiang Yong Tai Pharma Co., Ltd. romanized | 国药准字H20244077See source | 2024/06/18 | Official source ↗ |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 国药准字H20233577See source | 2023/05/19 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223006See source | 2022/01/07 | Official source ↗ |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H20213851See source | 2021/11/03 | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20213609See source | 2021/07/28 | Official source ↗ |
| Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized | 国药准字H20213553See source | 2021/06/29 | Official source ↗ |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20213500See source | 2021/06/16 | Official source ↗ |
| HEXAL AG | 国药准字HJ20210032See source | 2021/05/19 | Official source ↗ |
| Jiangsu Tian Yi Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20213323See source | 2021/04/30 | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203516See source | 2020/10/15 | Official source ↗ |
| Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized | 国药准字H20203433See source | 2020/08/17 | Official source ↗ |
| Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 国药准字H20203062See source | 2020/02/25 | Official source ↗ |
| Nanjing Sheng He Pharma Co., Ltd. romanized | 国药准字H20193432See source | 2019/12/30 | Official source ↗ |
| Chongqing Huapont Pharmaceutical Co., Ltd. | 国药准字H20193406See source | 2019/12/26 | Official source ↗ |
| Nanjing You Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20193387See source | 2019/12/18 | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20183096See source | 2019/12/17 | Official source ↗ |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20183530See source | 2018/12/25 | Official source ↗ |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20183246See source | 2018/07/06 | Official source ↗ |
| Bayer Vital GmbH | H20140721;H20140722;H201407230.4g | 2002/08/30 | Official source ↗ |
NHSA approval numbers 32
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Bayer Vital GmbH | 国药准字J201500150.4g | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20183096See source | — | Official source ↗ |
| Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 国药准字H20203062See source | — | Official source ↗ |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689See source | — | Official source ↗ |
| Chongqing Huapont Pharmaceutical Co., Ltd. | 国药准字H20193406See source | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079See source | — | Official source ↗ |
| Nanjing Sheng He Pharma Co., Ltd. romanized | 国药准字H20193432See source | — | Official source ↗ |
| Sichuan Di Fei Te Pharma Co., Ltd. romanized | 国药准字H20255081See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203516See source | — | Official source ↗ |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20253104See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223006See source | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20253145See source | — | Official source ↗ |
| Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20256080See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789See source | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20213609See source | — | Official source ↗ |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 国药准字H20233577See source | — | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H20213367See source | — | Official source ↗ |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20213500See source | — | Official source ↗ |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H20213851See source | — | Official source ↗ |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20183246See source | — | Official source ↗ |
| Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized | 国药准字H20203433See source | — | Official source ↗ |
| Bayer Vital GmbH | 国药准字HJ201407210.4g | — | Official source ↗ |
| Nanjing You Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20193387See source | — | Official source ↗ |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20183530See source | — | Official source ↗ |
| Zhejiang Yong Tai Pharma Co., Ltd. romanized | 国药准字H20244077See source | — | Official source ↗ |
| Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized | 国药准字H20213553See source | — | Official source ↗ |
| Xin Tian Di Pharma Co., Ltd. romanized | 国药准字H20264303See source | — | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20244634See source | — | Official source ↗ |
| Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264233See source | — | Official source ↗ |
| Jiangsu Tian Yi Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20213323See source | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20183096See source | — | Official source ↗ |
| Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 国药准字H20203062See source | — | Official source ↗ |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689See source | — | Official source ↗ |
| Chongqing Huapont Pharmaceutical Co., Ltd. | 国药准字H20193406See source | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079See source | — | Official source ↗ |
| Nanjing Sheng He Pharma Co., Ltd. romanized | 国药准字H20193432See source | — | Official source ↗ |
| Sichuan Di Fei Te Pharma Co., Ltd. romanized | 国药准字H20255081See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203516See source | — | Official source ↗ |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20253104See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223006See source | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20253145See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789See source | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20213609See source | — | Official source ↗ |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 国药准字H20233577See source | — | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H20213367See source | — | Official source ↗ |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20213500See source | — | Official source ↗ |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H20213851See source | — | Official source ↗ |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20183246See source | — | Official source ↗ |
| Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized | 国药准字H20203433See source | — | Official source ↗ |
| Bayer Vital GmbH | 国药准字HJ201407220.4g | — | Official source ↗ |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20183530See source | — | Official source ↗ |
| Zhejiang Yong Tai Pharma Co., Ltd. romanized | 国药准字H20244077See source | — | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20244634See source | — | Official source ↗ |
| Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264233See source | — | Official source ↗ |
| Jiangsu Tian Yi Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20213323See source | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20183096See source | — | Official source ↗ |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689See source | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079See source | — | Official source ↗ |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20253104See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223006See source | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20253145See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789See source | — | Official source ↗ |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 国药准字H20233577See source | — | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H20213367See source | — | Official source ↗ |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20213500See source | — | Official source ↗ |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H20213851See source | — | Official source ↗ |
| Bayer Vital GmbH | 国药准字HJ201407220.4g | — | Official source ↗ |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20183530See source | — | Official source ↗ |
| Zhejiang Yong Tai Pharma Co., Ltd. romanized | 国药准字H20244077See source | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20183096See source | — | Official source ↗ |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689See source | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079See source | — | Official source ↗ |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20253104See source | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20253145See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789See source | — | Official source ↗ |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 国药准字H20233577See source | — | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H20213367See source | — | Official source ↗ |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20213500See source | — | Official source ↗ |
| Gui Lin Nan Yao Co., Ltd. romanized | 国药准字H20213851See source | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20183096See source | — | Official source ↗ |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689See source | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079See source | — | Official source ↗ |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20253104See source | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20253145See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789See source | — | Official source ↗ |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 国药准字H20233577See source | — | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H20213367See source | — | Official source ↗ |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20213500See source | — | Official source ↗ |
| Bayer Vital GmbH | 国药准字HJ201407230.4g | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20183096See source | — | Official source ↗ |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689See source | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079See source | — | Official source ↗ |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20253104See source | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20253145See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789See source | — | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H20213367See source | — | Official source ↗ |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20213500See source | — | Official source ↗ |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689See source | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079See source | — | Official source ↗ |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20253104See source | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20253145See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789See source | — | Official source ↗ |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20213500See source | — | Official source ↗ |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689See source | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079See source | — | Official source ↗ |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20253104See source | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20253145See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789See source | — | Official source ↗ |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20213500See source | — | Official source ↗ |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689See source | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079See source | — | Official source ↗ |
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20253145See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789See source | — | Official source ↗ |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | 国药准字H20254689See source | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789See source | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789See source | — | Official source ↗ |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20244079See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789See source | — | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20263789See source | — | Official source ↗ |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20183246See source | — | Official source ↗ |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20183530See source | — | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20244634See source | — | Official source ↗ |
| Jiangsu Tian Yi Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20213323See source | — | Official source ↗ |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20183530See source | — | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20244634See source | — | Official source ↗ |
| Jiangsu Tian Yi Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20213323See source | — | Official source ↗ |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20183530See source | — | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20244634See source | — | Official source ↗ |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20183530See source | — | Official source ↗ |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20183530See source | — | Official source ↗ |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20183246See source | — | Official source ↗ |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20183246See source | — | Official source ↗ |
Under review 11
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Bayer Vital GmbH; Bayer HealthCare Manufacturing S.r.l. | JYHB2600455 | 2026/08/12 | Official source ↗ |
| Sichuan Gowell Pharmaceutical Co., Ltd. | CYHB2600779 | 2026/04/18 | Official source ↗ |
| Shanghai Jin Bu Huan Lan Kao Pharmaceutical Co., Ltd. romanized | CYHS2600411 | 2026/02/09 | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | CYHS2600143 | 2026/01/12 | Official source ↗ |
| Jiangxi Hong Shuo Pharmaceutical Co., Ltd. romanized | CYHS2504102 | 2025/11/28 | Official source ↗ |
| Zhengzhou Han Dou Pharma Group Co., Ltd. romanized | CYHS2503969 | 2025/11/15 | Official source ↗ |
| Jilin Dao Jun Pharma Co., Ltd. romanized | CYHS2503917 | 2025/11/11 | Official source ↗ |
| Bayer Vital GmbH; Bayer HealthCare Manufacturing S.r.l.; Name not romanized | JYHB2500581 | 2025/10/31 | Official source ↗ |
| Bayer Vital GmbH; Bayer HealthCare Manufacturing S.r.l. | JYHB2500580 | 2025/10/31 | Official source ↗ |
| Bayer Vital GmbH; Bayer HealthCare Manufacturing S.r.l. | JYHB2500579 | 2025/10/31 | Official source ↗ |
| Hainan Hai Li Pharmaceutical Co., Ltd. romanized | CYHS2501805 | 2025/05/17 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shanghai Jin Bu Huan Lan Kao Pharmaceutical Co., Ltd. romanized | CYHS2600411 | 2026/02/09 | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | CYHS2600143 | 2026/01/12 | Official source ↗ |
API companies with A status 48
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | Y20230001071 | 2025/07/22 | Official source ↗ |
| Zhejiang Xin He Cheng Co., Ltd. romanized | Y20230000900 | 2026/03/31 | Official source ↗ |
| Hebei Tian Cheng Pharma Co., Ltd. romanized | Y20220000887 | 2024/07/09 | Official source ↗ |
| Hebei Kai Wei Kang Ling Pharmaceutical Co., Ltd. romanized | Y20220000860 | 2024/12/04 | Official source ↗ |
| Shandong Lukang Pharmaceutical Co.,Ltd. | Y20220000493 | 2025/12/24 | Official source ↗ |
| Yi Chang Dong Yang Guang Pharmaceutical Co., Ltd. romanized | Y20220000196 | 2025/09/06 | Official source ↗ |
| Heilongjiang Zhen Bao Dao Pharma Co., Ltd. Ji Xi Branch romanized | Y20220000100 | 2025/06/07 | Official source ↗ |
| Changzhou Hong Tai Yang Pharma Co., Ltd. romanized | Y20210001254 | 2024/04/28 | Official source ↗ |
| Chongqing Shi Nan An Qu Jiang Qiao Lu 8 Hao romanized | Y20210001098 | 2026/07/16 | Official source ↗ |
| Xin Tian Di Pharma Co., Ltd. romanized | Y20210000980 | 2026/02/27 | Official source ↗ |
| Anhui Jian Feng Bei Ka Pharma Co., Ltd. romanized | Y20210000527 | 2025/12/23 | Official source ↗ |
| Liao Yuan Shi Yin Ying Pharmaceutical Co., Ltd. romanized | Y20210000273 | 2026/07/28 | Official source ↗ |
| Zhejiang Liao Yuan Pharma Co., Ltd. romanized | Y20210000103 | 2023/05/05 | Official source ↗ |
| Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized | Y20200000494 | 2022/08/03 | Official source ↗ |
| Sichuan Gowell Pharmaceutical Co., Ltd. | Y20190009766 | 2026/09/08 | Official source ↗ |
| Nanjing You Ke Pharmaceutical Co., Ltd. romanized | Y20190006998 | 2023/03/24 | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | Y20190000968 | 2026/06/18 | Official source ↗ |
| Sichuan Gowell Pharmaceutical Co., Ltd. | Y20190000446 | 2026/09/08 | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | Y20190000466 | 2025/09/24 | Official source ↗ |
| Zhejiang Xin He Cheng Co., Ltd. romanized | Y20190000343 | 2025/07/23 | Official source ↗ |
| Zhejiang Guo Bang Pharma Co., Ltd. romanized | Y20180001255 | 2025/11/27 | Official source ↗ |
| Jiangsu Tian Yi Shi Pharmaceutical Co., Ltd. romanized | Y20180001088 | 2026/04/24 | Official source ↗ |
| Gui Lin Nan Yao Co., Ltd. romanized | Y20170002212 | 2025/11/15 | Official source ↗ |
| Sichuan Xin Kai Yuan Pharmaceutical Co., Ltd. romanized | Y20170001688 | 2026/06/23 | Official source ↗ |
| Zhejiang Hai Zheng Pharma Co., Ltd. romanized | Y20170001678 | 2025/12/27 | Official source ↗ |
| Nanjing Sheng He Pharma Co., Ltd. romanized | Y20170001585 | 2024/06/06 | Official source ↗ |
| Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized | Y20170001536 | 2022/10/20 | Official source ↗ |
| MSN Pharmachem Private Limited | Y20170001468 | 2025/12/09 | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | Y20170001426 | 2024/08/27 | Official source ↗ |
| Dr.Reddy's Laboratories Ltd. | Y20170001362 | 2023/04/02 | Official source ↗ |
| Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized | Y20170001318 | 2026/09/18 | Official source ↗ |
| Shanxi Tong Da Pharma Co., Ltd. romanized | Y20170001220 | 2022/10/24 | Official source ↗ |
| Hetero Drugs Limited | Y20170001086 | 2025/11/21 | Official source ↗ |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | Y20170001062 | 2025/07/28 | Official source ↗ |
| Sichuan Xie Li Pharmaceutical Co., Ltd. romanized | Y20170001005 | 2024/02/08 | Official source ↗ |
| Shaanxi Da Sheng Pharmaceutical Technology Co., Ltd. romanized | Y20170000927 | 2024/02/08 | Official source ↗ |
| Hebei Guo Long Pharmaceutical Co., Ltd. romanized | Y20170000871 | 2025/09/16 | Official source ↗ |
| Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | Y20170000820 | 2023/09/14 | Official source ↗ |
| Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized | Y20170000806 | 2025/03/20 | Official source ↗ |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | Y20170000798 | 2025/07/19 | Official source ↗ |
| Zhejiang Xin He Cheng Co., Ltd. romanized | Y20170000789 | 2023/03/24 | Official source ↗ |
| Chengdu Tong De Pharma Co., Ltd. romanized | Y20170000786 | 2023/03/24 | Official source ↗ |
| Shandong Qidu Pharmaceutical Co., Ltd. | Y20170000737 | 2024/01/12 | Official source ↗ |
| Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | Y20170000682 | 2024/01/17 | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | Y20170000640 | 2026/04/30 | Official source ↗ |
| Chongqing Sheng Kai Pharmaceutical Co., Ltd. romanized | Y20170000595 | 2026/08/22 | Official source ↗ |
| Tianjin Hong Ri Pharma Co., Ltd. romanized | Y20170000298 | 2024/11/26 | Official source ↗ |
| Sichuan Qing Mu Pharmaceutical Co., Ltd. romanized | Y20170000255 | 2026/03/03 | Official source ↗ |
| Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20170000034 | 2025/12/31 | Official source ↗ |
| Shaanxi Tai Bai Shan Pharmaceutical Co., Ltd. romanized | Y20170000024 | 2022/10/21 | Official source ↗ |
| Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanized | Y20170000007 | 2024/04/19 | 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 ↗ · 13-19 · 2018/02/26
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