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Sign in to subscribeEscitalopram Oxalate Tablets
Matched- Active ingredients (original)
- ESCITALOPRAM OXALATE
- 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 approval2002/08/14
ANDA applications17
RLD applicantABBVIE INC
Currently marketed products: 39 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A076765-001 | ESCITALOPRAM OXALATE | TEVA PHARMACEUTICALS USA | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 5MG BASE | 2012/03/14 | N / N | DISCONTINUED | openFDA ↗ |
| A076765-002 | ESCITALOPRAM OXALATE | TEVA PHARMACEUTICALS USA | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 10MG BASE | 2012/03/14 | N / N | DISCONTINUED | openFDA ↗ |
| A076765-003 | ESCITALOPRAM OXALATE | TEVA PHARMACEUTICALS USA | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 20MG BASE | 2012/03/14 | N / N | DISCONTINUED | openFDA ↗ |
| A077512-001 | ESCITALOPRAM OXALATE | AIPING PHARMACEUTICAL INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 5MG BASE | 2012/09/12 | N / N | DISCONTINUED | openFDA ↗ |
| A077512-002 | ESCITALOPRAM OXALATE | AIPING PHARMACEUTICAL INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 10MG BASE | 2012/09/12 | N / N | DISCONTINUED | openFDA ↗ |
| A077512-003 | ESCITALOPRAM OXALATE | AIPING PHARMACEUTICAL INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 20MG BASE | 2012/09/12 | N / N | DISCONTINUED | openFDA ↗ |
| A077550-001 | ESCITALOPRAM OXALATE | NOVITIUM PHARMA LLC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 5MG BASE | 2015/05/14 | N / N | DISCONTINUED | openFDA ↗ |
| A077550-002 | ESCITALOPRAM OXALATE | NOVITIUM PHARMA LLC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 10MG BASE | 2015/05/14 | N / N | DISCONTINUED | openFDA ↗ |
| A077550-003 | ESCITALOPRAM OXALATE | NOVITIUM PHARMA LLC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 20MG BASE | 2015/05/14 | N / N | DISCONTINUED | openFDA ↗ |
| A077734-001 | ESCITALOPRAM OXALATE | ZYDUS LIFESCIENCES LTD | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 5MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077734-002 | ESCITALOPRAM OXALATE | ZYDUS LIFESCIENCES LTD | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 10MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077734-003 | ESCITALOPRAM OXALATE | ZYDUS LIFESCIENCES LTD | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 20MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078032-001 | ESCITALOPRAM OXALATE | PRINSTON PHARMACEUTICAL INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 5MG BASE | 2015/08/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078032-002 | ESCITALOPRAM OXALATE | PRINSTON PHARMACEUTICAL INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 10MG BASE | 2015/08/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078032-003 | ESCITALOPRAM OXALATE | PRINSTON PHARMACEUTICAL INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 20MG BASE | 2015/08/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078169-001 | ESCITALOPRAM OXALATE | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 5MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078169-002 | ESCITALOPRAM OXALATE | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 10MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078169-003 | ESCITALOPRAM OXALATE | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 20MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078604-001 | ESCITALOPRAM OXALATE | INVAGEN PHARMACEUTICALS INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 5MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078604-002 | ESCITALOPRAM OXALATE | INVAGEN PHARMACEUTICALS INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 10MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078604-003 | ESCITALOPRAM OXALATE | INVAGEN PHARMACEUTICALS INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 20MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078766-001 | ESCITALOPRAM OXALATE | HIKMA PHARMACEUTICALS | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 5MG BASE | 2012/09/11 | N / N | DISCONTINUED | openFDA ↗ |
| A078766-002 | ESCITALOPRAM OXALATE | HIKMA PHARMACEUTICALS | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 10MG BASE | 2012/09/11 | N / N | DISCONTINUED | openFDA ↗ |
| A078766-003 | ESCITALOPRAM OXALATE | HIKMA PHARMACEUTICALS | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 20MG BASE | 2012/09/11 | N / N | DISCONTINUED | openFDA ↗ |
| A078777-001 | ESCITALOPRAM OXALATE | GRAVITI PHARMACEUTICALS PRIVATE LTD | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 5MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078777-002 | ESCITALOPRAM OXALATE | GRAVITI PHARMACEUTICALS PRIVATE LTD | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 10MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078777-003 | ESCITALOPRAM OXALATE | GRAVITI PHARMACEUTICALS PRIVATE LTD | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 20MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090432-001 | ESCITALOPRAM OXALATE | AUROBINDO PHARMA LTD | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 5MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090432-002 | ESCITALOPRAM OXALATE | AUROBINDO PHARMA LTD | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 10MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090432-003 | ESCITALOPRAM OXALATE | AUROBINDO PHARMA LTD | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 20MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090939-001 | ESCITALOPRAM OXALATE | TORRENT PHARMACEUTICALS LTD | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 5MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090939-002 | ESCITALOPRAM OXALATE | TORRENT PHARMACEUTICALS LTD | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 10MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A090939-003 | ESCITALOPRAM OXALATE | TORRENT PHARMACEUTICALS LTD | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 20MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A091655-001 | ESCITALOPRAM OXALATE | MICRO LABS LTD | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 5MG BASE | 2026/04/22 | N / N | DISCONTINUED | openFDA ↗ |
| A091655-002 | ESCITALOPRAM OXALATE | MICRO LABS LTD | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 10MG BASE | 2026/04/22 | N / N | DISCONTINUED | openFDA ↗ |
| A091655-003 | ESCITALOPRAM OXALATE | MICRO LABS LTD | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 20MG BASE | 2026/04/22 | N / N | DISCONTINUED | openFDA ↗ |
| A202210-001 | ESCITALOPRAM OXALATE | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 5MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202210-002 | ESCITALOPRAM OXALATE | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 10MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202210-003 | ESCITALOPRAM OXALATE | MACLEODS PHARMACEUTICALS LTD | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 20MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202280-001 | ESCITALOPRAM OXALATE | JUBILANT CADISTA PHARMACEUTICALS INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 5MG BASE | 2012/09/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202280-002 | ESCITALOPRAM OXALATE | JUBILANT CADISTA PHARMACEUTICALS INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 10MG BASE | 2012/09/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202280-003 | ESCITALOPRAM OXALATE | JUBILANT CADISTA PHARMACEUTICALS INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 20MG BASE | 2012/09/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202389-001 | ESCITALOPRAM OXALATE | ACCORD HEALTHCARE INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 5MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202389-002 | ESCITALOPRAM OXALATE | ACCORD HEALTHCARE INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 10MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A202389-003 | ESCITALOPRAM OXALATE | ACCORD HEALTHCARE INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 20MG BASE | 2012/09/11 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205619-001 | ESCITALOPRAM OXALATE | AMNEAL PHARMACEUTICALS | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 5MG BASE | 2017/05/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205619-002 | ESCITALOPRAM OXALATE | AMNEAL PHARMACEUTICALS | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 10MG BASE | 2017/05/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205619-003 | ESCITALOPRAM OXALATE | AMNEAL PHARMACEUTICALS | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 20MG BASE | 2017/05/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215177-001 | ESCITALOPRAM OXALATE | ASCENT PHARMACEUTICALS INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 5MG BASE | 2025/07/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215177-002 | ESCITALOPRAM OXALATE | ASCENT PHARMACEUTICALS INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 10MG BASE | 2025/07/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A215177-003 | ESCITALOPRAM OXALATE | ASCENT PHARMACEUTICALS INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 20MG BASE | 2025/07/15 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021323-001 | LEXAPRO | ABBVIE INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 5MG BASE | 2002/08/14 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021323-002 | LEXAPRO | ABBVIE INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 10MG BASE | 2002/08/14 | Y / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N021323-003 | LEXAPRO | ABBVIE INC | TABLET | ORAL | ESCITALOPRAM OXALATE: EQ 20MG BASE | 2002/08/14 | Y / Y | HUMAN PRESCRIPTION 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: 2026/05/12
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| N021323-001 | NPP | 2026/05/12 | openFDA ↗ |
| N021323-002 | NPP | 2026/05/12 | openFDA ↗ |
| N021323-003 | NPP | 2026/05/12 | openFDA ↗ |
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 18
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shenyang Hua Tai Drug Research Co., Ltd. romanized | 国药准字H20264751See source | 2026/06/10 | Official source ↗ |
| Anhui Jiu Zhou Fang Yuan Pharmaceutical Co., Ltd. romanized | 国药准字H20244517See source | 2024/07/30 | Official source ↗ |
| Anhui Jiu Zhou Fang Yuan Pharmaceutical Co., Ltd. romanized | 国药准字H20244518See source | 2024/07/30 | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20243682See source | 2024/05/15 | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20234593See source | 2023/12/05 | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20234592See source | 2023/12/05 | Official source ↗ |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20234063See source | 2023/08/29 | Official source ↗ |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20234062See source | 2023/08/29 | Official source ↗ |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | 国药准字H20233260See source | 2023/03/07 | Official source ↗ |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | 国药准字H20233261See source | 2023/03/07 | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223609See source | 2022/08/23 | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223607See source | 2022/08/23 | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223608See source | 2022/08/23 | Official source ↗ |
| Lek Pharmaceuticals d.d. | 国药准字HJ20220003See source | 2022/01/30 | Official source ↗ |
| Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20213474See source | 2021/06/16 | Official source ↗ |
| Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20213475See source | 2021/06/16 | Official source ↗ |
| Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20213473See source | 2021/06/16 | Official source ↗ |
| Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized | 国药准字H201301055mg | 2021/04/20 | Official source ↗ |
| Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized | 国药准字H2013010610mg | 2021/04/20 | Official source ↗ |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20213259See source | 2021/04/07 | Official source ↗ |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20213260See source | 2021/04/07 | Official source ↗ |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20213258See source | 2021/04/07 | Official source ↗ |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20213257See source | 2021/04/07 | Official source ↗ |
| Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized | 国药准字H20213193See source | 2021/03/23 | Official source ↗ |
| Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized | 国药准字H20140108See source | 2020/09/25 | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20184142See source | 2020/09/04 | Official source ↗ |
| Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized | 国药准字H20140109See source | 2020/01/20 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20193308See source | 2019/11/04 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20193300See source | 2019/11/04 | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103327See source | 2018/09/26 | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20080599See source | 2018/09/26 | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103548See source | 2018/09/26 | Official source ↗ |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H20143391See source | 2018/05/14 | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H2008078810mg | 2018/02/07 | Official source ↗ |
| H. Lundbeck A/S | H2014012120mg | 2009/04/16 | Official source ↗ |
| H. Lundbeck A/S | H201501615mg | 2005/08/31 | Official source ↗ |
| H. Lundbeck A/S | H2015016310mg | 2005/08/31 | Official source ↗ |
NHSA approval numbers 35
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20234592See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20184142See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20080788See source | — | Official source ↗ |
| Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized | 国药准字H20140109See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103327See source | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223607See source | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20243682See source | — | Official source ↗ |
| Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized | 国药准字H20213193See source | — | Official source ↗ |
| Zhejiang Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20213473See source | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20193308See source | — | Official source ↗ |
| Zhejiang Hai Sen Pharma Co., Ltd. romanized | 国药准字H2013010610mg | — | Official source ↗ |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H20143391See source | — | Official source ↗ |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20213257See source | — | Official source ↗ |
| H. Lundbeck A/S | 国药准字HJ20150163See source | — | Official source ↗ |
| Lek Pharmaceuticals d.d. | 国药准字HJ20220003See source | — | Official source ↗ |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20234062See source | — | Official source ↗ |
| Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20244517See source | — | Official source ↗ |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | 国药准字H20233260See source | — | Official source ↗ |
| Shenyang Hua Tai Drug Research Co., Ltd. romanized | 国药准字H20264751See source | — | Official source ↗ |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H20263660See source | — | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20234592See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20184142See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20080788See source | — | Official source ↗ |
| Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized | 国药准字H20140109See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103327See source | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223607See source | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20243682See source | — | Official source ↗ |
| Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized | 国药准字H20213193See source | — | Official source ↗ |
| Zhejiang Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20213473See source | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20193308See source | — | Official source ↗ |
| Zhejiang Hai Sen Pharma Co., Ltd. romanized | 国药准字H2013010610mg | — | Official source ↗ |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H20143391See source | — | Official source ↗ |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20213257See source | — | Official source ↗ |
| H. Lundbeck A/S | 国药准字HJ20150163See source | — | Official source ↗ |
| Lek Pharmaceuticals d.d. | 国药准字HJ20220003See source | — | Official source ↗ |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | 国药准字H20233260See source | — | Official source ↗ |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H20263660See source | — | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20234592See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20184142See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20080788See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103327See source | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223607See source | — | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20243682See source | — | Official source ↗ |
| Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized | 国药准字H20213193See source | — | Official source ↗ |
| Zhejiang Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20213473See source | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20193308See source | — | Official source ↗ |
| Zhejiang Hai Sen Pharma Co., Ltd. romanized | 国药准字H2013010610mg | — | Official source ↗ |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H20143391See source | — | Official source ↗ |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | 国药准字H20233260See source | — | Official source ↗ |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H20263660See source | — | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20234592See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20184142See source | — | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20080788See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103327See source | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223607See source | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20193308See source | — | Official source ↗ |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H20143391See source | — | Official source ↗ |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H20263660See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103327See source | — | Official source ↗ |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H20263660See source | — | Official source ↗ |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | 国药准字H20263660See source | — | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20234593See source | — | Official source ↗ |
| Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized | 国药准字H20140108See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103548See source | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223608See source | — | Official source ↗ |
| Zhejiang Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20213474See source | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20193300See source | — | Official source ↗ |
| Zhejiang Hai Sen Pharma Co., Ltd. romanized | 国药准字H201301055mg | — | Official source ↗ |
| Dong Guan Shi Yang Zhi Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20213258See source | — | Official source ↗ |
| H.Lundbeck A/S | H20150161See source | — | Official source ↗ |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20234063See source | — | Official source ↗ |
| Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20244518See source | — | Official source ↗ |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | 国药准字H20233261See source | — | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20234593See source | — | Official source ↗ |
| Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized | 国药准字H20140108See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103548See source | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223608See source | — | Official source ↗ |
| Zhejiang Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20213474See source | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20193300See source | — | Official source ↗ |
| Zhejiang Hai Sen Pharma Co., Ltd. romanized | 国药准字H201301055mg | — | Official source ↗ |
| H.Lundbeck A/S | H20150161See source | — | Official source ↗ |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | 国药准字H20233261See source | — | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20234593See source | — | Official source ↗ |
| Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized | 国药准字H20140108See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103548See source | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223608See source | — | Official source ↗ |
| Zhejiang Hua Yuan Pharma Co., Ltd. romanized | 国药准字H20213474See source | — | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20193300See source | — | Official source ↗ |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | 国药准字H20233261See source | — | Official source ↗ |
| Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 国药准字H20234593See source | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223608See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20080599See source | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223609See source | — | Official source ↗ |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20213475See source | — | Official source ↗ |
| Zhejiang Hai Sen Pharma Co., Ltd. romanized | 国药准字H2013010610mg | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20080599See source | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223609See source | — | Official source ↗ |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20213475See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20080599See source | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223609See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20080599See source | — | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20223609See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20080599See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20080599See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20080599See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20080599See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103327See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103327See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103327See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103548See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20103548See source | — | Official source ↗ |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | 国药准字H20080599See source | — | Official source ↗ |
Under review 6
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shanghai Shyndec Pharmaceutical Co., Ltd. | CYHS2602144 | 2026/08/27 | Official source ↗ |
| Shanghai Shyndec Pharmaceutical Co., Ltd. | CYHS2602143 | 2026/08/27 | Official source ↗ |
| Wuhan Ren Fu Pharma Co., Ltd. romanized | CYHS2602037 | 2026/08/18 | Official source ↗ |
| Wuhan Ren Fu Pharma Co., Ltd. romanized | CYHS2602036 | 2026/08/18 | Official source ↗ |
| Maxmind Pharmaceutical S.L.; Macleods Pharmaceuticals Ltd.; Maxmind Biotechnology (Hainan) Co. Ltd. | JYHS2400060 | 2024/12/05 | Official source ↗ |
| Maxmind Pharmaceutical S.L.; Macleods Pharmaceuticals Ltd.; Maxmind Biotechnology (Hainan) Co. Ltd. | JYHS2400059 | 2024/12/05 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shanghai Shyndec Pharmaceutical Co., Ltd. | CYHS2602144 | 2026/08/27 | Official source ↗ |
| Shanghai Shyndec Pharmaceutical Co., Ltd. | CYHS2602143 | 2026/08/27 | Official source ↗ |
| Wuhan Ren Fu Pharma Co., Ltd. romanized | CYHS2602037 | 2026/08/18 | Official source ↗ |
| Wuhan Ren Fu Pharma Co., Ltd. romanized | CYHS2602036 | 2026/08/18 | Official source ↗ |
API companies with A status 16
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Virupaksha Organics Limited | Y20240000675 | 2026/04/21 | Official source ↗ |
| Hetero Labs Limited | Y20210001164 | 2024/12/29 | Official source ↗ |
| Olon S.p.A. | Y20190021297 | 2022/10/27 | Official source ↗ |
| Shandong Rui Shun Pharma Co., Ltd. romanized | Y20190009855 | 2024/01/17 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20190009839 | 2026/05/20 | Official source ↗ |
| Sichuan Kelun Pharmaceutical Co., Ltd. | Y20190008922 | 2024/07/26 | Official source ↗ |
| Shandong An Xin Pharmaceutical Co., Ltd. romanized | Y20190008896 | 2024/04/30 | Official source ↗ |
| Zhejiang Hai Sen Pharma Co., Ltd. romanized | Y20190007282 | 2023/08/16 | Official source ↗ |
| Wuxi Ji Da Pharmaceutical Co., Ltd. romanized | Y20190006965 | 2023/03/24 | Official source ↗ |
| Hunan Dong Ting Pharma Co., Ltd. romanized | Y20190001441 | 2024/10/18 | Official source ↗ |
| Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized | Y20190001382 | 2025/08/09 | Official source ↗ |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20180001104 | 2026/05/20 | Official source ↗ |
| Shandong Rui Shun Pharma Co., Ltd. romanized | Y20170001891 | 2024/09/26 | Official source ↗ |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20170001449 | 2024/02/08 | Official source ↗ |
| Shanghai Shyndec Pharmaceutical Co., Ltd. | Y20170001293 | 2024/01/18 | Official source ↗ |
| Rui Yang Pharmaceutical Co., Ltd. romanized | Y20170001283 | 2025/01/03 | Official source ↗ |
| Ru Yuan Dong Yang Guang Pharma Co., Ltd. romanized | Y20170000762 | 2023/08/10 | Official source ↗ |
| Wan Quan Wan Te Pharmaceutical Jiangsu Co., Ltd. romanized | Y20170000654 | 2023/03/24 | 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 ↗ · 27-312 · 2020/06/04
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