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Matched- Active ingredients (original)
- OLOPATADINE HYDROCHLORIDE
- Dosage form (original)
- SOLUTION/DROPS
- Route (original)
- OPHTHALMIC
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 approval1996/12/18
ANDA applications25
RLD applicantALCON LABORATORIES INC
Currently marketed products: 22 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A078350-001 | OLOPATADINE HYDROCHLORIDE | APOTEX INC | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.1% BASE | 2015/12/07 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A090848-001 | OLOPATADINE HYDROCHLORIDE | BARR LABORATORIES INC | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.2% BASE | 2015/07/13 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A090918-001 | OLOPATADINE HYDROCHLORIDE | APOTEX INC | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.2% BASE | 2017/12/05 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A200810-001 | OLOPATADINE HYDROCHLORIDE | GLENMARK PHARMACEUTICALS INC USA | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.1% BASE | 2017/06/28 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A203152-001 | OLOPATADINE HYDROCHLORIDE | USV PRIVATE LTD | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.1% BASE | 2015/12/07 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A204392-001 | OLOPATADINE HYDROCHLORIDE | RISING PHARMA HOLDINGS INC | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.1% BASE | 2018/03/21 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A204532-001 | OLOPATADINE HYDROCHLORIDE | SCIEGEN PHARMACEUTICALS INC | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.1% BASE | 2017/01/10 | N / N | DISCONTINUED | openFDA ↗ |
| A204620-001 | OLOPATADINE HYDROCHLORIDE | RISING PHARMA HOLDINGS INC | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.2% BASE | 2020/06/16 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A204706-001 | OLOPATADINE HYDROCHLORIDE | ZAMBON SPA | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.1% BASE | 2015/12/07 | N / N | DISCONTINUED | openFDA ↗ |
| A204723-001 | OLOPATADINE HYDROCHLORIDE | SCIEGEN PHARMACEUTICALS INC | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.2% BASE | 2017/12/05 | N / N | DISCONTINUED | openFDA ↗ |
| A204812-001 | OLOPATADINE HYDROCHLORIDE | EUGIA PHARMA SPECIALITIES LTD | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.1% BASE | 2015/12/18 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A206046-001 | OLOPATADINE HYDROCHLORIDE | BAUSCH AND LOMB INC | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.1% BASE | 2017/07/26 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A206087-001 | OLOPATADINE HYDROCHLORIDE | BAUSCH AND LOMB INC | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.2% BASE | 2017/12/05 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A206306-001 | OLOPATADINE HYDROCHLORIDE | SOMERSET THERAPEUTICS LLC | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.1% BASE | 2015/12/07 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A208637-001 | OLOPATADINE HYDROCHLORIDE | REGCON HOLDINGS LLC | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.7% BASE | 2020/02/19 | N / N | DISCONTINUED | openFDA ↗ |
| A209282-001 | OLOPATADINE HYDROCHLORIDE | FDC LTD | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.1% BASE | 2019/09/26 | N / N | DISCONTINUED | openFDA ↗ |
| A209420-001 | OLOPATADINE HYDROCHLORIDE | ALEMBIC PHARMACEUTICALS LTD | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.2% BASE | 2019/04/29 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A209619-001 | OLOPATADINE HYDROCHLORIDE | GLAND PHARMA LTD | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.1% BASE | 2019/08/02 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A209752-001 | OLOPATADINE HYDROCHLORIDE | GLAND PHARMA LTD | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.2% BASE | 2020/05/20 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A209919-001 | OLOPATADINE HYDROCHLORIDE | ALEMBIC PHARMACEUTICALS LTD | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.1% BASE | 2018/12/07 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A209995-001 | OLOPATADINE HYDROCHLORIDE | EUGIA PHARMA SPECIALITIES LTD | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.2% BASE | 2019/04/04 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A213514-001 | OLOPATADINE HYDROCHLORIDE | GLAND PHARMA LTD | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.7% BASE | 2026/01/06 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A215006-001 | OLOPATADINE HYDROCHLORIDE | SOMERSET THERAPEUTICS LLC | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.2% BASE | 2024/12/18 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A217051-001 | OLOPATADINE HYDROCHLORIDE | FDC LTD | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.2% BASE | 2025/07/14 | N / N | DISCONTINUED | openFDA ↗ |
| A219557-001 | OLOPATADINE HYDROCHLORIDE | GLENMARK PHARMACEUTICALS INC USA | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.2% BASE | 2025/02/28 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| N020688-001 | PATADAY TWICE DAILY RELIEF | ALCON LABORATORIES INC | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.1% BASE | 1996/12/18 | Y / Y | HUMAN OTC DRUG | openFDA ↗ |
| N021545-001 | PATADAY ONCE DAILY RELIEF | ALCON LABORATORIES INC | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.2% BASE | 2004/12/22 | Y / Y | HUMAN OTC DRUG | openFDA ↗ |
| N206276-001 | PATADAY ONCE DAILY RELIEF | ALCON LABORATORIES INC | SOLUTION/DROPS | OPHTHALMIC | OLOPATADINE HYDROCHLORIDE: EQ 0.7% BASE | 2015/01/30 | 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 expiration2032/05/19
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 |
|---|---|---|---|---|---|---|
| N206276-001 | 8791154 | 2032/05/19 | — / Y | U-1680 | — | openFDA ↗ |
| N206276-001 | 9533053 | 2032/05/19 | — / Y | — | — | openFDA ↗ |
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: —
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| Not listed | |||
Chinese record details
Chinese product landscape ↗The four-zero filter applies only to matched rows: catalog holders, NHSA approval numbers, applications under review, and companies filing generics this year. Unmatched rows have no Chinese counts. Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.
Catalog holders 1
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Novartis Europharm Limited | H20181146See source | 2002/06/13 | Official source ↗ |
NHSA approval numbers 43
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guangdong Nan Guo Pharma Co., Ltd. romanized | 国药准字H20265833See source | — | Official source ↗ |
| Shan Tou Jing Ji Te Qu Ming Zhi Pharmaceuticals Co., Ltd. romanized | 国药准字H20254147See source | — | Official source ↗ |
| Shenzhen Wan He Pharmaceutical Co., Ltd. romanized | 国药准字H20253371See source | — | Official source ↗ |
| Shenyang Xing Qi Yan Yao Co., Ltd. romanized | 国药准字H20193101See source | — | Official source ↗ |
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | 国药准字H20255814See source | — | Official source ↗ |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20183349See source | — | Official source ↗ |
| Suzhou Le Zhu Pharmaceutical Co., Ltd. romanized | 国药准字H20243121See source | — | Official source ↗ |
| Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized | 国药准字H20249048See source | — | Official source ↗ |
| Wuhan Wu Jing Pharma Co., Ltd. romanized | 国药准字H20264530See source | — | Official source ↗ |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H20244478See source | — | Official source ↗ |
| Chengdu Pusch Pharmaceutical Co., Ltd. | 国药准字H20234561See source | — | Official source ↗ |
| Hebei Chuang Jian Pharma Co., Ltd. romanized | 国药准字H200838260.1% | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20249754See source | — | Official source ↗ |
| Changchun Di Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20263810See source | — | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20183099See source | — | Official source ↗ |
| Hefei Hua Wei Pharma Co., Ltd. romanized | 国药准字H20233973See source | — | Official source ↗ |
| Guo Yao Group San Yi Pharma (Wu Hu) Co., Ltd. romanized | 国药准字H20243943See source | — | Official source ↗ |
| Zhejiang Jian Feng Pharma Co., Ltd. romanized | 国药准字H20193095See source | — | Official source ↗ |
| Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | 国药准字H20253402See source | — | Official source ↗ |
| Jiangxi Ma Ying Long Mei Kang Pharma Co., Ltd. romanized | 国药准字H20255181See source | — | Official source ↗ |
| Jiangxi Ke Lun Pharma Co., Ltd. romanized | 国药准字H20183402See source | — | Official source ↗ |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | 国药准字H20233103See source | — | Official source ↗ |
| Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20234503See source | — | Official source ↗ |
| Guangdong Hong Ying Technology Co., Ltd. romanized | 国药准字H20173398See source | — | Official source ↗ |
| Can Tian Pharmaceutical (Zhongguo) Co., Ltd. romanized | 国药准字H20183436See source | — | Official source ↗ |
| Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized | 国药准字H20203419See source | — | Official source ↗ |
| Ya Bang Pharmaceuticals Co., Ltd. romanized | 国药准字H20265956See source | — | Official source ↗ |
| Hebei Chuang Jian Pharma Co., Ltd. romanized | 国药准字H20234645See source | — | Official source ↗ |
| Novartis Europharm Limited | 国药准字HJ20181146See source | — | Official source ↗ |
| Novartis pharmaceuticals Corporation | 国药准字HJ20200062See source | — | Official source ↗ |
| Hua Run Zi Zhu Pharma Co., Ltd. romanized | 国药准字H20243440See source | — | Official source ↗ |
| Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized | 国药准字H20258231See source | — | Official source ↗ |
| Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | 国药准字H20233505See source | — | Official source ↗ |
| Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20256442See source | — | Official source ↗ |
| Ai Er Health Yan Yao (Liaoning) Co., Ltd. romanized | 国药准字H20243749See source | — | Official source ↗ |
| Ai Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20249046See source | — | Official source ↗ |
| Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized | 国药准字H20249048See source | — | Official source ↗ |
| Wuhan Wu Jing Pharma Co., Ltd. romanized | 国药准字H20264530See source | — | Official source ↗ |
| Chengdu Pusch Pharmaceutical Co., Ltd. | 国药准字H20234561See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20249754See source | — | Official source ↗ |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | 国药准字H20233103See source | — | Official source ↗ |
| Hua Run Zi Zhu Pharma Co., Ltd. romanized | 国药准字H20243440See source | — | Official source ↗ |
| Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized | 国药准字H20249048See source | — | Official source ↗ |
| Wuhan Wu Jing Pharma Co., Ltd. romanized | 国药准字H20264530See source | — | Official source ↗ |
| Chengdu Pusch Pharmaceutical Co., Ltd. | 国药准字H20234561See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20249754See source | — | Official source ↗ |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | 国药准字H20233103See source | — | Official source ↗ |
| Hua Run Zi Zhu Pharma Co., Ltd. romanized | 国药准字H20243440See source | — | Official source ↗ |
| Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized | 国药准字H20249048See source | — | Official source ↗ |
| Chengdu Pusch Pharmaceutical Co., Ltd. | 国药准字H20234561See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20249754See source | — | Official source ↗ |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | 国药准字H20233103See source | — | Official source ↗ |
| Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized | 国药准字H20249048See source | — | Official source ↗ |
| Chengdu Pusch Pharmaceutical Co., Ltd. | 国药准字H20234561See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20249754See source | — | Official source ↗ |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | 国药准字H20233103See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20249754See source | — | Official source ↗ |
| Shenyang Xing Qi Yan Yao Co., Ltd. romanized | 国药准字H20249276See source | — | Official source ↗ |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20183349See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20249755See source | — | Official source ↗ |
| Changchun Di Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20263809See source | — | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20204033See source | — | Official source ↗ |
| Zhejiang Jian Feng Pharma Co., Ltd. romanized | 国药准字H20247155See source | — | Official source ↗ |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | 国药准字H20233103See source | — | Official source ↗ |
| Guangdong Hong Ying Technology Co., Ltd. romanized | 国药准字H20173398See source | — | Official source ↗ |
| Hua Run Zi Zhu Pharma Co., Ltd. romanized | 国药准字H20243440See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20249755See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20249755See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20249755See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20249755See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20249755See source | — | Official source ↗ |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20183349See source | — | Official source ↗ |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | 国药准字H20254150See source | — | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20204033See source | — | Official source ↗ |
| Guangdong Hong Ying Technology Co., Ltd. romanized | 国药准字H20173398See source | — | Official source ↗ |
| Hua Run Zi Zhu Pharma Co., Ltd. romanized | 国药准字H20233951See source | — | Official source ↗ |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20183349See source | — | Official source ↗ |
| Guangdong Hong Ying Technology Co., Ltd. romanized | 国药准字H20173398See source | — | Official source ↗ |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20183349See source | — | Official source ↗ |
| Jiangsu Guang Cheng Pharma Co., Ltd. romanized | 国药准字H20183349See source | — | Official source ↗ |
Under review 13
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2601339 | 2026/06/08 | Official source ↗ |
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | CYHB2502477 | 2025/12/05 | Official source ↗ |
| Nanjing Di Chang Pharmaceuticals Technology Co., Ltd. romanized; Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized | CYHS2602464 | 2026/10/09 | Official source ↗ |
| Zhen Shi Ming (Jiangxi) Pharma Co., Ltd. romanized | CYHS2602205 | 2026/09/04 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | CYHS2601145 | 2026/05/14 | Official source ↗ |
| Chengdu Pusch Pharmaceutical Co., Ltd. | CYHB2600909 | 2026/05/13 | Official source ↗ |
| Shandong Bo Shi Lun Fu Rui Da Pharmaceutical Co., Ltd. romanized | CYHS2600880 | 2026/04/17 | Official source ↗ |
| Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized | CYHS2600474 | 2026/02/13 | Official source ↗ |
| Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized | CYHS2504403 | 2025/12/25 | Official source ↗ |
| Novartis Europharm Limited; Novartis Manufacturing NV | JYHB2500521 | 2025/10/14 | Official source ↗ |
| Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized | CYHS2503239 | 2025/09/03 | Official source ↗ |
| Sichuan He Yi Pharmaceutical Co., Ltd. romanized | CYHS2502362 | 2025/07/04 | Official source ↗ |
| Guangzhou Wei Ao Kang Pharma Technology Co., Ltd. romanized; Guangzhou Hua Sheng Pharmaceutical Co., Ltd. romanized | CYHS2501637 | 2025/05/01 | Official source ↗ |
Generic-filing companies this year 6
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2601339 | 2026/06/08 | Official source ↗ |
| Nanjing Di Chang Pharmaceuticals Technology Co., Ltd. romanized; Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized | CYHS2602464 | 2026/10/09 | Official source ↗ |
| Zhen Shi Ming (Jiangxi) Pharma Co., Ltd. romanized | CYHS2602205 | 2026/09/04 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | CYHS2601145 | 2026/05/14 | Official source ↗ |
| Shandong Bo Shi Lun Fu Rui Da Pharmaceutical Co., Ltd. romanized | CYHS2600880 | 2026/04/17 | Official source ↗ |
| Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized | CYHS2600474 | 2026/02/13 | Official source ↗ |
API companies with A status 16
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shijiazhuang Gree Pharmaceutical Co., Ltd | Y20230000466 | 2025/09/29 | Official source ↗ |
| Xin Xiang Hai Bin Pharma Co., Ltd. romanized | Y20220001158 | 2024/06/21 | Official source ↗ |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | Y20200001291 | 2023/01/04 | Official source ↗ |
| Sichuan Zi Ren Pharmaceutical Co., Ltd. romanized | Y20200000735 | 2022/10/28 | Official source ↗ |
| Hebei Chuang Jian Pharma Co., Ltd. romanized | Y20200000675 | 2024/02/21 | Official source ↗ |
| CURIA SPAIN S.A.U. | Y20190009103 | 2026/10/14 | Official source ↗ |
| CRYSTAL PHARMA S.A.U. | Y20190009102 | — | Official source ↗ |
| Kyowa Hakko Kirin Co.,Ltd. | Y20190009080 | — | Official source ↗ |
| Chongqing Xi Nan Pharmaceutical Er Factory Co., Ltd. romanized | Y20190008886 | — | Official source ↗ |
| Changzhou Ya Bang Pharmaceutical Co., Ltd. romanized | Y20190008405 | 2024/08/29 | Official source ↗ |
| Wu Yi Ci Hang Pharma Co., Ltd. romanized | Y20190007169 | 2023/03/24 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | Y20190006800 | — | Official source ↗ |
| Jin Cheng Hai Si Pharmaceutical Co., Ltd. romanized | Y20170001002 | 2023/05/16 | Official source ↗ |
| PCAS Finland Oy | Y20170000692 | 2024/10/29 | Official source ↗ |
| MSN Laboratories Private Limited | Y20170000299 | 2024/12/31 | Official source ↗ |
| Chongqing Sheng Kai Pharmaceutical Co., Ltd. romanized | Y20170000273 | 2025/04/22 | 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 ↗ · 56-41 · 2022/09/13
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- Export the complete loaded event timeline for each followed product as CSV.
- Add up to 4 additional recipients, each confirmed by email.
- Increase your follow limit from 3 to 10 products.
Quarterly
US$540
Billed every three months
US$180 per month
Sign in to subscribeYearly
US$1,920
Billed every year
US$160 per month
Sign in to subscribeNeed more than 10 followed products or more than 5 recipients? Contact us.
Separate one-time purchase
US Orange Book × China records comparison
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
Subscriptions and comparison-table access are purchased separately. Neither includes the other.
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