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Matched- Active ingredients (original)
- VARDENAFIL 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 approval2003/08/19
ANDA applications6
RLD applicantBAYER HEALTHCARE PHARMACEUTICALS INC
Currently marketed products: 20 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A091347-001 | VARDENAFIL HYDROCHLORIDE | TEVA PHARMACEUTICALS USA | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 2.5MG BASE | 2012/05/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A091347-002 | VARDENAFIL HYDROCHLORIDE | TEVA PHARMACEUTICALS USA | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 5MG BASE | 2012/05/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A091347-003 | VARDENAFIL HYDROCHLORIDE | TEVA PHARMACEUTICALS USA | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 10MG BASE | 2012/05/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A091347-004 | VARDENAFIL HYDROCHLORIDE | TEVA PHARMACEUTICALS USA | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 20MG BASE | 2012/05/03 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204632-001 | VARDENAFIL HYDROCHLORIDE | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 2.5MG BASE | 2019/10/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204632-002 | VARDENAFIL HYDROCHLORIDE | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 5MG BASE | 2019/10/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204632-003 | VARDENAFIL HYDROCHLORIDE | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 10MG BASE | 2019/10/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A204632-004 | VARDENAFIL HYDROCHLORIDE | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 20MG BASE | 2019/10/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208960-001 | VARDENAFIL HYDROCHLORIDE | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 2.5MG BASE | 2018/10/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208960-002 | VARDENAFIL HYDROCHLORIDE | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 5MG BASE | 2018/10/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208960-003 | VARDENAFIL HYDROCHLORIDE | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 10MG BASE | 2018/10/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208960-004 | VARDENAFIL HYDROCHLORIDE | ZYDUS PHARMACEUTICALS USA INC | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 20MG BASE | 2018/10/31 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A209057-001 | VARDENAFIL HYDROCHLORIDE | CROSSMEDIKA SA | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 2.5MG BASE | 2018/10/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A209057-002 | VARDENAFIL HYDROCHLORIDE | CROSSMEDIKA SA | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 5MG BASE | 2018/10/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A209057-003 | VARDENAFIL HYDROCHLORIDE | CROSSMEDIKA SA | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 10MG BASE | 2018/10/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A209057-004 | VARDENAFIL HYDROCHLORIDE | CROSSMEDIKA SA | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 20MG BASE | 2018/10/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210738-001 | VARDENAFIL HYDROCHLORIDE | JEROME STEVENS PHARMACEUTICALS INC | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 5MG BASE | 2018/10/31 | N / N | DISCONTINUED | openFDA ↗ |
| A210738-002 | VARDENAFIL HYDROCHLORIDE | JEROME STEVENS PHARMACEUTICALS INC | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 10MG BASE | 2018/10/31 | N / N | DISCONTINUED | openFDA ↗ |
| A210738-003 | VARDENAFIL HYDROCHLORIDE | JEROME STEVENS PHARMACEUTICALS INC | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 20MG BASE | 2018/10/31 | N / N | DISCONTINUED | openFDA ↗ |
| A214031-001 | VARDENAFIL HYDROCHLORIDE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 2.5MG BASE | 2020/08/04 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214031-002 | VARDENAFIL HYDROCHLORIDE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 5MG BASE | 2020/08/04 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214031-003 | VARDENAFIL HYDROCHLORIDE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 10MG BASE | 2020/08/04 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214031-004 | VARDENAFIL HYDROCHLORIDE | ALEMBIC PHARMACEUTICALS LTD | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 20MG BASE | 2020/08/04 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021400-001 | LEVITRA | BAYER HEALTHCARE PHARMACEUTICALS INC | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2003/08/19 | Y / N | DISCONTINUED | openFDA ↗ |
| N021400-002 | LEVITRA | BAYER HEALTHCARE PHARMACEUTICALS INC | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2003/08/19 | Y / N | DISCONTINUED | openFDA ↗ |
| N021400-003 | LEVITRA | BAYER HEALTHCARE PHARMACEUTICALS INC | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2003/08/19 | Y / N | DISCONTINUED | openFDA ↗ |
| N021400-004 | LEVITRA | BAYER HEALTHCARE PHARMACEUTICALS INC | TABLET | ORAL | VARDENAFIL HYDROCHLORIDE: EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2003/08/19 | 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 expiration2027/07/23
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 |
|---|---|---|---|---|---|---|
| N021400-001 | 8273876 | 2027/07/23 | — / — | U-1288 | — | openFDA ↗ |
| N021400-002 | 8273876 | 2027/07/23 | — / — | U-1288 | — | openFDA ↗ |
| N021400-003 | 8273876 | 2027/07/23 | — / — | U-1288 | — | openFDA ↗ |
| N021400-004 | 8273876 | 2027/07/23 | — / — | U-1288 | — | 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 15
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | 2026/08/04 | Official source ↗ |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20264800See source | 2026/06/17 | Official source ↗ |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20264799See source | 2026/06/17 | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | 2026/03/25 | Official source ↗ |
| Jiangxi Hui Ren Pharma Co., Ltd. romanized | 国药准字H20256414See source | 2025/12/30 | Official source ↗ |
| Jiangxi Hui Ren Pharma Co., Ltd. romanized | 国药准字H20256415See source | 2025/12/30 | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20254953See source | 2025/07/29 | Official source ↗ |
| Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized | 国药准字H20254173See source | 2025/05/13 | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130See source | 2025/05/13 | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129See source | 2025/05/13 | Official source ↗ |
| Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249572See source | 2024/12/01 | Official source ↗ |
| Guo Yao Holding Xing Sha Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H20249431See source | 2024/11/22 | Official source ↗ |
| Zhejiang Shi Qiang Pharmaceutical Co., Ltd. romanized | 国药准字H20249029See source | 2024/10/09 | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20244792See source | 2024/09/03 | Official source ↗ |
| Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20243123See source | 2024/01/30 | Official source ↗ |
| Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20243124See source | 2024/01/30 | Official source ↗ |
| Yangtze River Pharmaceutical Group Co., Ltd | 国药准字H20233768See source | 2023/06/21 | Official source ↗ |
| Guangxi Qiang Shou Pharma Group Co., Ltd. romanized | 国药准字H20233690See source | 2023/06/07 | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203339See source | 2020/07/21 | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338See source | 2020/07/21 | Official source ↗ |
| Bayer AG | H20140495;H2014049720mg | 2004/08/05 | Official source ↗ |
NHSA approval numbers 16
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized | 国药准字H20254173See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130See source | — | Official source ↗ |
| Yangtze River Pharmaceutical Group Co., Ltd | 国药准字H20233768See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338See source | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20254953See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20244792See source | — | Official source ↗ |
| Zhejiang Shi Qiang Pharmaceutical Co., Ltd. romanized | 国药准字H20249029See source | — | Official source ↗ |
| Guo Yao Holding Xing Sha Pharmaceutical (Xiamen) Co., Ltd. romanized | 国药准字H20249431See source | — | Official source ↗ |
| Guangxi Qiang Shou Pharma Group Co., Ltd. romanized | 国药准字H20233690See source | — | Official source ↗ |
| Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249572See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20243123See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338See source | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20254953See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20244792See source | — | Official source ↗ |
| Guangxi Qiang Shou Pharma Group Co., Ltd. romanized | 国药准字H20233690See source | — | Official source ↗ |
| Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249572See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20243123See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20244792See source | — | Official source ↗ |
| Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249572See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20243123See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20244792See source | — | Official source ↗ |
| Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249572See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338See source | — | Official source ↗ |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20244792See source | — | Official source ↗ |
| Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249572See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338See source | — | Official source ↗ |
| Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249572See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338See source | — | Official source ↗ |
| Shandong Hai Ya Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249572See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203338See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254130See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20263715See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203339See source | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20254953See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20243124See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203339See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20243124See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203339See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20203339See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20254129See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20265478See source | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20254953See source | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20254953See source | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20254953See source | — | Official source ↗ |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20254953See source | — | Official source ↗ |
Under review 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hangzhou Min Sheng Drug Research Institute Co., Ltd. romanized; Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2502733 | 2025/07/30 | Official source ↗ |
| Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanized | CYHS2601846 | 2026/07/31 | Official source ↗ |
| Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanized | CYHS2601845 | 2026/07/31 | Official source ↗ |
| Zhejiang Ying Ge Lai Pharmaceutical Co., Ltd. romanized | CYHS2600690 | 2026/03/21 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanized | CYHS2601846 | 2026/07/31 | Official source ↗ |
| Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized; Yang Ling Bu Zhang Pharmaceutical Co., Ltd. romanized | CYHS2601845 | 2026/07/31 | Official source ↗ |
| Zhejiang Ying Ge Lai Pharmaceutical Co., Ltd. romanized | CYHS2600690 | 2026/03/21 | Official source ↗ |
API companies with A status 9
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shanghai He Quan Pharma Co., Ltd. romanized | Y20230001158 | 2025/07/29 | Official source ↗ |
| Yang Ling Ji Tai Pharma Co., Ltd. romanized | Y20230000021 | 2024/10/17 | Official source ↗ |
| Alembic Pharmaceuticals Limited | Y20210000075 | 2024/06/28 | Official source ↗ |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | Y20210000746 | 2023/09/27 | Official source ↗ |
| Guangxi Qiang Shou Pharma Group Co., Ltd. romanized | Y20210000500 | 2024/01/17 | Official source ↗ |
| Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20210000036 | 2025/01/11 | Official source ↗ |
| Jin Hong Pharma Co., Ltd., Jin Hong Pharma Co., Ltd. romanized | Y20200001095 | 2024/04/19 | Official source ↗ |
| Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | Y20180001528 | 2024/02/07 | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | Y20180000752 | 2025/04/23 | 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 ↗ · 28-16 · 2020/06/04
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