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Sign in to subscribeFexofenadine Hydrochloride Tablets
Matched- Active ingredients (original)
- FEXOFENADINE 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 approval2005/08/31
ANDA applications14
RLD applicantCHATTEM INC DBA SANOFI CONSUMER HEALTHCARE
Currently marketed products: 36 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A076191-001 | FEXOFENADINE HYDROCHLORIDE | BARR LABORATORIES INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 30MG | 2005/08/31 | N / N | DISCONTINUED | openFDA ↗ |
| A076191-002 | FEXOFENADINE HYDROCHLORIDE | BARR LABORATORIES INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2005/08/31 | N / N | DISCONTINUED | openFDA ↗ |
| A076191-003 | FEXOFENADINE HYDROCHLORIDE | BARR LABORATORIES INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2005/08/31 | N / N | DISCONTINUED | openFDA ↗ |
| A076447-001 | FEXOFENADINE HYDROCHLORIDE | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 30MG | 2005/09/01 | N / N | DISCONTINUED | openFDA ↗ |
| A076447-002 | FEXOFENADINE HYDROCHLORIDE | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2005/09/01 | N / N | DISCONTINUED | openFDA ↗ |
| A076447-003 | FEXOFENADINE HYDROCHLORIDE | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2005/09/01 | N / N | DISCONTINUED | openFDA ↗ |
| A076447-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 30MG | 2011/04/13 | N / N | DISCONTINUED | openFDA ↗ |
| A076447-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 30MG | 2011/04/13 | N / N | DISCONTINUED | openFDA ↗ |
| A076447-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2011/04/13 | N / N | DISCONTINUED | openFDA ↗ |
| A076447-007 | FEXOFENADINE HYDROCHLORIDE HIVES | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2011/04/13 | N / N | DISCONTINUED | openFDA ↗ |
| A076447-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2011/04/13 | N / N | DISCONTINUED | openFDA ↗ |
| A076502-001 | FEXOFENADINE HYDROCHLORIDE | DR REDDYS LABORATORIES LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 30MG | 2006/04/11 | N / N | DISCONTINUED | openFDA ↗ |
| A076502-002 | FEXOFENADINE HYDROCHLORIDE | DR REDDYS LABORATORIES LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2006/04/11 | N / N | DISCONTINUED | openFDA ↗ |
| A076502-003 | FEXOFENADINE HYDROCHLORIDE | DR REDDYS LABORATORIES LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2006/04/11 | N / N | DISCONTINUED | openFDA ↗ |
| A076502-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | DR REDDYS LABORATORIES LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 30MG | 2011/04/12 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A076502-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | DR REDDYS LABORATORIES LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 30MG | 2011/04/12 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A076502-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | DR REDDYS LABORATORIES LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2011/04/12 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A076502-007 | FEXOFENADINE HYDROCHLORIDE HIVES | DR REDDYS LABORATORIES LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2011/04/12 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A076502-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | DR REDDYS LABORATORIES LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2011/04/12 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A076502-009 | FEXOFENADINE HYDROCHLORIDE HIVES | DR REDDYS LABORATORIES LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2011/04/12 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A077081-001 | FEXOFENADINE HYDROCHLORIDE | RISING PHARMA HOLDINGS INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2007/04/16 | N / N | DISCONTINUED | openFDA ↗ |
| A077081-002 | FEXOFENADINE HYDROCHLORIDE | RISING PHARMA HOLDINGS INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 30MG | 2008/04/11 | N / N | DISCONTINUED | openFDA ↗ |
| A077081-003 | FEXOFENADINE HYDROCHLORIDE | RISING PHARMA HOLDINGS INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2008/04/11 | N / N | DISCONTINUED | openFDA ↗ |
| A077081-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | RISING PHARMA HOLDINGS INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 30MG | 2011/07/21 | N / N | DISCONTINUED | openFDA ↗ |
| A077081-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | RISING PHARMA HOLDINGS INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 30MG | 2011/07/21 | N / N | DISCONTINUED | openFDA ↗ |
| A077081-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | RISING PHARMA HOLDINGS INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2011/07/21 | N / N | DISCONTINUED | openFDA ↗ |
| A077081-007 | FEXOFENADINE HYDROCHLORIDE HIVES | RISING PHARMA HOLDINGS INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2011/07/21 | N / N | DISCONTINUED | openFDA ↗ |
| A077081-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | RISING PHARMA HOLDINGS INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2011/07/21 | N / N | DISCONTINUED | openFDA ↗ |
| A077081-009 | FEXOFENADINE HYDROCHLORIDE HIVES | RISING PHARMA HOLDINGS INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2011/07/21 | N / N | DISCONTINUED | openFDA ↗ |
| A079112-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | PHARMAZONE | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 30MG | 2012/02/08 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A079112-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | PHARMAZONE | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 30MG | 2012/02/08 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A079112-003 | FEXOFENADINE HYDROCHLORIDE HIVES | PHARMAZONE | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2012/02/08 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A079112-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | PHARMAZONE | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2012/02/08 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A079112-005 | FEXOFENADINE HYDROCHLORIDE HIVES | PHARMAZONE | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2012/02/08 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A079112-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | PHARMAZONE | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2012/02/08 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 30MG | 2012/02/06 | N / N | DISCONTINUED | openFDA ↗ |
| A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 30MG | 2012/02/06 | N / N | DISCONTINUED | openFDA ↗ |
| A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2012/02/06 | N / N | DISCONTINUED | openFDA ↗ |
| A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2012/02/06 | N / N | DISCONTINUED | openFDA ↗ |
| A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2012/02/06 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2012/02/06 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | AUROBINDO PHARMA LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 30MG | 2014/11/19 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | AUROBINDO PHARMA LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2014/11/19 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | AUROBINDO PHARMA LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2014/11/19 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | HETERO LABS LTD UNIT V | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 30MG | 2016/08/19 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | HETERO LABS LTD UNIT V | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2016/08/19 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | HETERO LABS LTD UNIT V | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2016/08/19 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | SCIEGEN PHARMACEUTICALS INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2015/09/16 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | SCIEGEN PHARMACEUTICALS INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2015/09/16 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | SCIEGEN PHARMACEUTICALS INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2015/09/16 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | SCIEGEN PHARMACEUTICALS INC | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2015/09/16 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2018/08/13 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A211075-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | GRANULES INDIA LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2019/10/18 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A211075-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | GRANULES INDIA LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2019/10/18 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A212971-001 | FEXOFENADINE HYDROCHLORIDE | L PERRIGO CO | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2020/02/24 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A212971-002 | FEXOFENADINE HYDROCHLORIDE | L PERRIGO CO | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2020/02/24 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A219032-001 | FEXOFENADINE HYDROCHLORIDE | CONTRACT PHARMACAL CORP | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2025/02/28 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A219032-002 | FEXOFENADINE HYDROCHLORIDE | CONTRACT PHARMACAL CORP | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2025/02/28 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A220413-001 | FEXOFENADINE HYDROCHLORIDE | DR REDDYS LABORATORIES LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2026/07/30 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A220413-002 | FEXOFENADINE HYDROCHLORIDE | DR REDDYS LABORATORIES LTD | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2026/07/30 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| N020872-005 | CHILDREN'S ALLEGRA ALLERGY | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2011/01/24 | Y / N | DISCONTINUED | openFDA ↗ |
| N020872-006 | CHILDREN'S ALLEGRA HIVES | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 30MG | 2011/01/24 | Y / N | DISCONTINUED | openFDA ↗ |
| N020872-007 | ALLEGRA ALLERGY | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2011/01/24 | Y / N | HUMAN OTC DRUG | openFDA ↗ |
| N020872-008 | ALLEGRA HIVES | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 60MG | 2011/01/24 | Y / N | DISCONTINUED | openFDA ↗ |
| N020872-009 | ALLEGRA HIVES | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2011/01/24 | Y / Y | HUMAN OTC DRUG | openFDA ↗ |
| N020872-010 | ALLEGRA ALLERGY | CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE | TABLET | ORAL | FEXOFENADINE HYDROCHLORIDE: 180MG | 2011/01/24 | Y / Y | HUMAN OTC DRUG | 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 4
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhejiang Wan Cheng Pharma Co., Ltd. romanized | 国药准字H2006014960mg | 2024/01/11 | Official source ↗ |
| Zhejiang Wan Cheng Pharma Co., Ltd. romanized | 国药准字H2006015030mg | 2024/01/11 | Official source ↗ |
| Sichuan Sheng Xu Hui Pharmaceutical Co., Ltd. romanized | 国药准字H2007012460mg | 2023/09/20 | Official source ↗ |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H2015322160mg | 2021/11/29 | Official source ↗ |
| Xian Wan Long Pharmaceutical Co., Ltd. romanized | 国药准字H2008071060mg | 2021/01/15 | Official source ↗ |
NHSA approval numbers 16
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Foyou Pharma CO.,LTD | 国药准字H2013004060mg | — | Official source ↗ |
| Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized | 国药准字H2006033060mg | — | Official source ↗ |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H20080437120mg | — | Official source ↗ |
| Sun Pharmaceutical Industries Ltd. | 国药准字HJ20170079120mg | — | Official source ↗ |
| Xian Wan Long Pharmaceutical Co., Ltd. romanized | 国药准字H2008071060mg | — | Official source ↗ |
| Sichuan Sheng Xu Hui Pharmaceutical Co., Ltd. romanized | 国药准字H2007012460mg | — | Official source ↗ |
| Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized | 国药准字H2006015030mg | — | Official source ↗ |
| Yunnan Yu Feng Pharma Co., Ltd. romanized | 国药准字H2008012330mg | — | Official source ↗ |
| OPELLA HEALTHCARE FRANCE SAS | 国药准字HJ20210012180mg | — | Official source ↗ |
| Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized | 国药准字H2015322160mg | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H2013004060mg | — | Official source ↗ |
| Sun Pharmaceutical Industries Ltd. | 国药准字HJ20170079120mg | — | Official source ↗ |
| Xian Wan Long Pharmaceutical Co., Ltd. romanized | 国药准字H2008071060mg | — | Official source ↗ |
| Heilongjiang Wu Su Li Jiang Pharmaceutical Co., Ltd. Haerbin Branch romanized | 国药准字H2009033360mg | — | Official source ↗ |
| Sichuan Sheng Xu Hui Pharmaceutical Co., Ltd. romanized | 国药准字H2007012460mg | — | Official source ↗ |
| Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized | 国药准字H2006015030mg | — | Official source ↗ |
| Yunnan Yu Feng Pharma Co., Ltd. romanized | 国药准字H2008012330mg | — | Official source ↗ |
| Sun Pharmaceutical Industries Ltd. | 国药准字HJ2017007760mg | — | Official source ↗ |
| OPELLA HEALTHCARE FRANCE SAS | 国药准字HJ20210012180mg | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H2013004060mg | — | Official source ↗ |
| Xian Wan Long Pharmaceutical Co., Ltd. romanized | 国药准字H2008071060mg | — | Official source ↗ |
| Heilongjiang Wu Su Li Jiang Pharmaceutical Co., Ltd. Haerbin Branch romanized | 国药准字H2009033360mg | — | Official source ↗ |
| Sichuan Sheng Xu Hui Pharmaceutical Co., Ltd. romanized | 国药准字H2007012460mg | — | Official source ↗ |
| Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized | 国药准字H2006015030mg | — | Official source ↗ |
| Yunnan Yu Feng Pharma Co., Ltd. romanized | 国药准字H2008012330mg | — | Official source ↗ |
| Sun Pharmaceutical Industries Ltd. | 国药准字HJ2017007760mg | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | 国药准字H2013004060mg | — | Official source ↗ |
| Heilongjiang Wu Su Li Jiang Pharmaceutical Co., Ltd. Haerbin Branch romanized | 国药准字H2009033360mg | — | Official source ↗ |
| Sichuan Sheng Xu Hui Pharmaceutical Co., Ltd. romanized | 国药准字H2007012460mg | — | Official source ↗ |
| Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized | 国药准字H2006015030mg | — | Official source ↗ |
| Sun Pharmaceutical Industries Ltd. | 国药准字HJ2017007760mg | — | Official source ↗ |
| Heilongjiang Wu Su Li Jiang Pharmaceutical Co., Ltd. Haerbin Branch romanized | 国药准字H2009033360mg | — | Official source ↗ |
| Sun Pharmaceutical Industries Ltd. | 国药准字HJ2017007760mg | — | Official source ↗ |
| Sun Pharmaceutical Industries Ltd. | 国药准字HJ2017007760mg | — | Official source ↗ |
| Sun Pharmaceutical Industries Ltd. | 国药准字HJ2017007760mg | — | Official source ↗ |
| Sun Pharmaceutical Industries Ltd. | 国药准字J2017003560mg | — | Official source ↗ |
| Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized | 国药准字H2006014960mg | — | Official source ↗ |
| Sun Pharmaceutical Industries Ltd. | H20170079120mg | — | Official source ↗ |
| Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized | 国药准字H2006014960mg | — | Official source ↗ |
| Sun Pharmaceutical Industries Ltd. | H20170079120mg | — | Official source ↗ |
| Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized | 国药准字H2006014960mg | — | Official source ↗ |
| Sun Pharmaceutical Industries Ltd. | 国药准字HJ20170080120mg | — | Official source ↗ |
| Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized | 国药准字H2006014960mg | — | Official source ↗ |
Under review 10
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES LIMITED | JYHZ2600273 | 2026/10/21 | Official source ↗ |
| SUN PHARMACEUTICAL INDUSTRIES LIMITED | JYHZ2600272 | 2026/10/21 | Official source ↗ |
| Hefei He Yuan Pharma Co., Ltd. romanized | CYHS2602222 | 2026/09/07 | Official source ↗ |
| Hefei He Yuan Pharma Co., Ltd. romanized | CYHS2602220 | 2026/09/07 | Official source ↗ |
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | CYHS2601983 | 2026/08/12 | Official source ↗ |
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | CYHS2601982 | 2026/08/12 | Official source ↗ |
| Zhi En Bio Technology Co., Ltd. romanized | CYHS2503071 | 2025/08/21 | Official source ↗ |
| Zhi En Bio Technology Co., Ltd. romanized | CYHS2503070 | 2025/08/21 | Official source ↗ |
| Zhi En Bio Technology Co., Ltd. romanized | CYHS2503069 | 2025/08/21 | Official source ↗ |
| Zhi En Bio Technology Co., Ltd. romanized | CYHS2503068 | 2025/08/21 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hefei He Yuan Pharma Co., Ltd. romanized | CYHS2602222 | 2026/09/07 | Official source ↗ |
| Hefei He Yuan Pharma Co., Ltd. romanized | CYHS2602220 | 2026/09/07 | Official source ↗ |
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | CYHS2601983 | 2026/08/12 | Official source ↗ |
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | CYHS2601982 | 2026/08/12 | Official source ↗ |
API companies with A status 17
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Chemeca Drugs Private Limited | Y20230000849 | 2026/10/15 | Official source ↗ |
| Vasudha Pharma Chem Ltd. | Y20220001219 | 2025/08/06 | Official source ↗ |
| Xian Wan Long Pharmaceutical Co., Ltd. romanized | Y20220000912 | 2024/06/07 | Official source ↗ |
| Ind-Swift Laboratories Limited | Y20190009263 | 2023/08/10 | Official source ↗ |
| Synthimed Labs Private Limited | Y20190009262 | 2026/08/11 | Official source ↗ |
| Zhejiang Le Pu Pharma Co., Ltd. romanized | Y20190007452 | 2024/02/28 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20190007370 | 2023/07/18 | Official source ↗ |
| Hainan Sha Ting Ning Pharmaceutical Co., Ltd. romanized | Y20190007145 | — | Official source ↗ |
| Beijing Foyou Pharma CO.,LTD | Y20190007111 | 2023/03/24 | Official source ↗ |
| Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized | Y20190006884 | 2023/03/24 | Official source ↗ |
| Sichuan Sheng Xu Hui Pharmaceutical Co., Ltd. romanized | Y20190006660 | — | Official source ↗ |
| Chongqing Zhi En Pharma Co., Ltd. romanized | Y20190006653 | — | Official source ↗ |
| Chi Zhou Dong Sheng Pharma Co., Ltd. romanized | Y20190006585 | 2026/04/20 | Official source ↗ |
| Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized | Y20190006077 | 2025/08/22 | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | Y20190004696 | 2025/08/01 | Official source ↗ |
| Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized | Y20190004565 | 2025/02/06 | Official source ↗ |
| Virupaksha Organics Ltd | Y20170000127 | 2026/08/07 | 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 ↗ · 31-110 · 2020/11/20
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