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Sign in to subscribeAs of 13 November 2026, for Pregabalin Capsules, 12 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 34 holders.
Companies, stages and changes, with each record available on this page.
Listed in the US FDA Orange Book as LYRICA (NDA 021446, UPJOHN US 2 LLC).
Last 90 days: Accepted: 2 applications
Current coverage may be incomplete
The brand names come from the US FDA Orange Book and describe US listing records for this active ingredient. They do not indicate that products under these brand names are approved or sold in China, or that Chinese applicants are affiliated with US holders.
Orange Book source export date: 2026/11/06. Version: 2026-11-06.
Showing 2 of 2 distinct brand names.
A brand with different source forms or statuses can appear on multiple rows and in both groups. Distinct brand names are counted once globally, with a limit of five.
Verified official English dosage form: Capsules. Listings are grouped by the source dosage form and route; records without a clear correspondence are listed in the other group. Grouping does not establish product equivalence.
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| LYRICA | UPJOHN US 2 LLC | NDA 021446 · Product no. 001, 002, 003, 004, 005, 006, 007, 008 | CAPSULE | ORAL | HUMAN PRESCRIPTION DRUG | 2004/12/30 |
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| LYRICA | UPJOHN US 2 LLC | NDA 022488 · Product no. 001 | SOLUTION | ORAL | HUMAN PRESCRIPTION DRUG | 2010/01/04 |
| LYRICA CR | UPJOHN US 2 LLC | NDA 209501 · Product no. 001, 002, 003 | TABLET, EXTENDED RELEASE | ORAL | HUMAN PRESCRIPTION DRUG | 2017/10/11 |
Same-form/route listings come first, followed by other forms/routes. Within each group, source prescription/OTC listings precede discontinued listings; unknown statuses are last. Each status bucket is ordered by earliest approval date, ascending: pre-1982 records first, missing dates last; ties by brand name, application number and product number. The first five distinct brands in this order are selected globally. All retained source facts for those brands are shown in their own groups; a brand spanning both groups counts once.
Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.
Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.
Loaded records: 34 holders; 1 in the quality-and-efficacy consistency-evaluation category, and 32 in the new chemical-registration-classification generic category. Category counts may overlap.
| Marketing authorization holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20264982 | 2026/06/30 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20264983 | 2026/06/30 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hui Zhi Pharmaceutical (Da Lian) Co., Ltd. romanized | Hui Zhi Pharmaceutical (Da Lian) Co., Ltd. romanized | 国药准字H20263111 | 2026/01/14 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hui Zhi Pharmaceutical (Da Lian) Co., Ltd. romanized | Hui Zhi Pharmaceutical (Da Lian) Co., Ltd. romanized | 国药准字H20263112 | 2026/01/14 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Da Tong Pharmaceutical (Zhongguo) Co., Ltd. romanized | Da Tong Pharmaceutical (Zhongguo) Co., Ltd. romanized | 国药准字H20253195 | 2025/01/14 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Da Tong Pharmaceutical (Zhongguo) Co., Ltd. romanized | Da Tong Pharmaceutical (Zhongguo) Co., Ltd. romanized | 国药准字H20253194 | 2025/01/14 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20253180 | 2025/01/14 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20253179 | 2025/01/14 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Sai Long Pharma Co., Ltd. romanized | Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized | 国药准字H20247280 | 2024/11/07 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanized | Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H20249116 | 2024/10/22 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanized | Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H20249115 | 2024/10/22 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Anhui Jiu Zhou Fang Yuan Pharmaceutical Co., Ltd. romanized | Anhui Jiu Zhou Fang Yuan Pharmaceutical Co., Ltd. romanized | 国药准字H20249082 | 2024/10/16 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu En Hua Pharma Co., Ltd. romanized | Jiangsu En Hua Pharma Co., Ltd. romanized | 国药准字H20243979 | 2024/06/11 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20243977 | 2024/06/11 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20243976 | 2024/06/11 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Ningbo Shuang Cheng Pharma Co., Ltd. romanized | Ningbo Shuang Cheng Pharma Co., Ltd. romanized | 国药准字H20243330 | 2024/03/12 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Ningbo Shuang Cheng Pharma Co., Ltd. romanized | Ningbo Shuang Cheng Pharma Co., Ltd. romanized | 国药准字H20243331 | 2024/03/12 | 300mg | Generic approved under the new chemical-drug registration classification | CDE |
| Ao Mei Pharmaceutical (Hainan) Co., Ltd. romanized | Ao Mei Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20243329 | 2024/03/12 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Ao Mei Pharmaceutical (Hainan) Co., Ltd. romanized | Ao Mei Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20243328 | 2024/03/12 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chongqing Pharmaceuticals (Group) Co., Ltd. romanized | Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H20243304 | 2024/03/05 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chongqing Pharmaceuticals (Group) Co., Ltd. romanized | Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H20243305 | 2024/03/05 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Nord Pharmaceutical Co., Ltd | Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243210 | 2024/02/23 | 100mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Nord Pharmaceutical Co., Ltd | Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243211 | 2024/02/23 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Sai Long Pharma Co., Ltd. romanized | Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized | 国药准字H20243261 | 2024/02/23 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Nord Pharmaceutical Co., Ltd | Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 2023/11/14 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Dan Hong Pharmaceutical Co., Ltd. romanized | Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized | 国药准字H20234016 | 2023/08/08 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Dan Hong Pharmaceutical Co., Ltd. romanized | Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized | 国药准字H20234017 | 2023/08/08 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Dr. Reddy’s Laboratories Limited | Dr. Reddy’s Laboratories Limited | 国药准字HJ20230097 | 2023/08/01 | 75mg | Not stated by source | CDE |
| Dr. Reddy’s Laboratories Limited | Dr. Reddy’s Laboratories Limited | 国药准字HJ20230098 | 2023/08/01 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Pharmaceutical Formulations Co., Ltd. romanized | Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 国药准字H20233922 | 2023/07/11 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Pharmaceutical Formulations Co., Ltd. romanized | Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 国药准字H20233923 | 2023/07/11 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| YaoPharma Co., Ltd. | YaoPharma Co., Ltd. | 国药准字H20233557 | 2023/05/19 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| YaoPharma Co., Ltd. | YaoPharma Co., Ltd. | 国药准字H20233558 | 2023/05/19 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| TC Pharmaceuticals (Jiangsu) Co., Ltd | TC Pharmaceuticals (Jiangsu) Co., Ltd | 国药准字H20233255 | 2023/03/07 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized | Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized | 国药准字H20233167 | 2023/02/14 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized | Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized | 国药准字H20233165 | 2023/02/14 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized | Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized | 国药准字H20233166 | 2023/02/14 | 100mg | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized | Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20233134 | 2023/02/07 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized | Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20233133 | 2023/02/07 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Ya Bao Pharma Tai Yuan Pharmaceutical Co., Ltd. romanized | Ya Bao Pharma Tai Yuan Pharmaceutical Co., Ltd. romanized | 国药准字H20223957 | 2022/12/30 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Ya Bao Pharma Tai Yuan Pharmaceutical Co., Ltd. romanized | Ya Bao Pharma Tai Yuan Pharmaceutical Co., Ltd. romanized | 国药准字H20223958 | 2022/12/30 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. | 国药准字H20223713 | 2022/09/30 | 100mg | Generic approved under the new chemical-drug registration classification | CDE |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. | 国药准字H20223712 | 2022/09/30 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized | Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized | 国药准字H20223587 | 2022/08/10 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized | Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized | 国药准字H20223588 | 2022/08/10 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20223305 | 2022/05/10 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20223306 | 2022/05/10 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20223307 | 2022/05/10 | 300mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Jin Rui Pharmaceutical Co., Ltd. romanized | Hainan Jin Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20223220 | 2022/04/12 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20213765 | 2021/09/30 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20213766 | 2021/09/30 | 100mg | Generic approved under the new chemical-drug registration classification | CDE |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20213767 | 2021/09/30 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213706 | 2021/09/07 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213703 | 2021/09/07 | 25mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213702 | 2021/09/07 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213705 | 2021/09/07 | 100mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213704 | 2021/09/07 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20213449 | 2021/06/01 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20213450 | 2021/06/01 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Wan Wei Pharmaceutical Co., Ltd. romanized | Hainan Wan Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20213340 | 2021/05/11 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Wan Wei Pharmaceutical Co., Ltd. romanized | Hainan Wan Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20213339 | 2021/05/11 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 国药准字H20203640 | 2020/12/02 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 国药准字H20203641 | 2020/12/02 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chongqing Sai Wei Pharma Co., Ltd. romanized | Chongqing Sai Wei Pharma Co., Ltd. romanized | 国药准字H20130064 | 2020/11/11 | 100mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Chongqing Sai Wei Pharma Co., Ltd. romanized | Chongqing Sai Wei Pharma Co., Ltd. romanized | 国药准字H20130073 | 2020/11/11 | 75mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Hua Run Shuang He Pharma Co., Ltd. romanized | Hua Run Shuang He Pharma Co., Ltd. romanized | 国药准字H20203551 | 2020/11/04 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hua Run Shuang He Pharma Co., Ltd. romanized | Hua Run Shuang He Pharma Co., Ltd. romanized | 国药准字H20203550 | 2020/11/04 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Name not romanized | Qilu Pharmaceutical (Hainan) Co., Ltd | 国药准字H20203041 | 2020/02/20 | 150mg | Generic approved under the new chemical-drug registration classification | CDE |
| Name not romanized | Qilu Pharmaceutical (Hainan) Co., Ltd | 国药准字H20203040 | 2020/02/20 | 75mg | Generic approved under the new chemical-drug registration classification | CDE |
| Pfizer Limited | Pfizer Manufacturing Deutschland GmbH, Betriebsstatte Freiburg | H20150625 | 2010/05/07 | 300mg | Imported originator drug | CDE |
| Pfizer Limited | Pfizer Manufacturing Deutschland GmbH, Betriebsstatte Freiburg | H20150624 | 2010/05/07 | 200mg | Imported originator drug | CDE |
| Pfizer Limited | Pfizer Manufacturing Deutschland GmbH,Betriebsstatte Freiburg | H20150622 | 2010/05/07 | 150mg | Imported originator drug | CDE |
| Pfizer Limited | Pfizer Manufacturing Deutschland GmbH, Betriebsstatte Freiburg | H20150621 | 2010/05/07 | 100mg | Imported originator drug | CDE |
| Pfizer Limited | Pfizer Manufacturing Deutschland GmbH, Betriebsstatte Freiburg | H20150619 | 2010/05/07 | 75mg | Imported originator drug | CDE |
| Pfizer Limited | Pfizer Manufacturing Deutschland GmbH, Betriebsstatte Freiburg | H20150618 | 2010/05/07 | 50mg | Imported originator drug | CDE |
| Pfizer Limited | Pfizer Manufacturing Deutschland GmbH, Betriebsstatte Freiburg | H20150617 | 2010/05/07 | 25mg | Imported originator drug | CDE |
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
Loaded records: 70 distinct approval numbers and 32 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Chongqing Pharmaceuticals (Group) Co., Ltd. romanized | 国药准字H20243304 | 75mg | Category B | XN02BGP112E001010101016 | NHSA |
| Chongqing Sai Wei Pharma Co., Ltd. romanized | 国药准字H20130064 | 100mg | Category B | XN02BGP112E001010101028 | NHSA |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H20233557 | 75mg | Category B | XN02BGP112E001010101066 | NHSA |
| Upjohn EESV | 国药准字J20160022 | 150mg | Category B | XN02BGP112E001010101187 | NHSA |
| Jiangsu En Hua Pharma Co., Ltd. romanized | 国药准字H20243979 | 75mg | Category B | XN02BGP112E001010101435 | NHSA |
| Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized | 国药准字H20223588 | 75mg | Category B | XN02BGP112E001010101748 | NHSA |
| De Quan Medicines (Jiangsu) Co., Ltd. romanized | 国药准字H20233255 | 75mg | Category B | XN02BGP112E001010101751 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20233133 | 75mg | Category B | XN02BGP112E001010102180 | NHSA |
| Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 国药准字H20233922 | 75mg | Category B | XN02BGP112E001010102297 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20213449 | 75mg | Category B | XN02BGP112E001010102770 | NHSA |
| Ya Bao Pharma Group Co., Ltd. romanized | 国药准字H20223957 | 75mg | Category B | XN02BGP112E001010102987 | NHSA |
| Shandong Dan Hong Pharmaceutical Co., Ltd. romanized | 国药准字H20234016 | 75mg | Category B | XN02BGP112E001010104073 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20243976 | 150mg | Category B | XN02BGP112E001010104187 | NHSA |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20203641 | 75mg | Category B | XN02BGP112E001010104565 | NHSA |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20253180 | 75mg | Category B | XN02BGP112E001010104606 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20213765 | 75mg | Category B | XN02BGP112E001010104647 | NHSA |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | 国药准字H20223712 | 75mg | Category B | XN02BGP112E001010104658 | NHSA |
| Ao Mei Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20243328 | 150mg | Category B | XN02BGP112E001010105760 | NHSA |
| Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20203040 | 75mg | Category B | XN02BGP112E001010105847 | NHSA |
| Dr.Reddy's Laboratories Limited | 国药准字HJ20230097 | 75mg | Category B | XN02BGP112E001010178377 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213703 | 25mg | Category B | XN02BGP112E001010179261 | NHSA |
| Hainan Jin Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20223220 | 75mg | Category B | XN02BGP112E001010179280 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20243261 | 150mg | Category B | XN02BGP112E001010179286 | NHSA |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20223305 | 75mg | Category B | XN02BGP112E001010180086 | NHSA |
| Da Tong Pharmaceutical (Zhongguo) Co., Ltd. romanized | 国药准字H20253194 | 75mg | Category B | XN02BGP112E001010180685 | NHSA |
| Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized | 国药准字H20233167 | 75mg | Category B | XN02BGP112E001010181274 | NHSA |
| Anhui Jiu Zhou Fang Yuan Pharmaceutical Co., Ltd. romanized | 国药准字H20249082 | 75mg | Category B | XN02BGP112E001010181400 | NHSA |
| Hua Run Shuang He Pharma Co., Ltd. romanized | 国药准字H20203550 | 75mg | Category B | XN02BGP112E001010181661 | NHSA |
| Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized | 国药准字H20233165 | 150mg | Category B | XN02BGP112E001010181979 | NHSA |
| Hainan Wan Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20213339 | 75mg | Category B | XN02BGP112E001010182249 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243211 | 75mg | Category B | XN02BGP112E001010183521 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20233134 | 150mg | Category B | XN02BGP112E001010183542 | NHSA |
| Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanized | 国药准字H20249115 | 75mg | Category B | XN02BGP112E001010183544 | NHSA |
| Chongqing Pharmaceuticals (Group) Co., Ltd. romanized | 国药准字H20243305 | 150mg | Category B | XN02BGP112E001010183661 | NHSA |
| Ningbo Shuang Cheng Pharma Co., Ltd. romanized | 国药准字H20243330 | 75mg | Category B | XN02BGP112E001010184155 | NHSA |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H20233557 | 75mg | Category B | XN02BGP112E001010201066 | NHSA |
| Upjohn EESV | 国药准字J20160022 | 150mg | Category B | XN02BGP112E001010201187 | NHSA |
| Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized | 国药准字H20223588 | 75mg | Category B | XN02BGP112E001010201748 | NHSA |
| De Quan Medicines (Jiangsu) Co., Ltd. romanized | 国药准字H20233255 | 75mg | Category B | XN02BGP112E001010201751 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20233133 | 75mg | Category B | XN02BGP112E001010202180 | NHSA |
| Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 国药准字H20233922 | 75mg | Category B | XN02BGP112E001010202297 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20213449 | 75mg | Category B | XN02BGP112E001010202770 | NHSA |
| Ya Bao Pharma Group Co., Ltd. romanized | 国药准字H20223957 | 75mg | Category B | XN02BGP112E001010202987 | NHSA |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20203641 | 75mg | Category B | XN02BGP112E001010204565 | NHSA |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20253180 | 75mg | Category B | XN02BGP112E001010204606 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20213765 | 75mg | Category B | XN02BGP112E001010204647 | NHSA |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | 国药准字H20223712 | 75mg | Category B | XN02BGP112E001010204658 | NHSA |
| Ao Mei Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20243328 | 150mg | Category B | XN02BGP112E001010205760 | NHSA |
| Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20203040 | 75mg | Category B | XN02BGP112E001010205847 | NHSA |
| Dr.Reddy's Laboratories Limited | 国药准字HJ20230097 | 75mg | Category B | XN02BGP112E001010278377 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213703 | 25mg | Category B | XN02BGP112E001010279261 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20243261 | 150mg | Category B | XN02BGP112E001010279286 | NHSA |
| Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized | 国药准字H20233167 | 75mg | Category B | XN02BGP112E001010281274 | NHSA |
| Hua Run Shuang He Pharma Co., Ltd. romanized | 国药准字H20203550 | 75mg | Category B | XN02BGP112E001010281661 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243211 | 75mg | Category B | XN02BGP112E001010283521 | NHSA |
| Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanized | 国药准字H20249115 | 75mg | Category B | XN02BGP112E001010283544 | NHSA |
| Chongqing Pharmaceuticals (Group) Co., Ltd. romanized | 国药准字H20243305 | 150mg | Category B | XN02BGP112E001010283661 | NHSA |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H20233557 | 75mg | Category B | XN02BGP112E001010301066 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20233133 | 75mg | Category B | XN02BGP112E001010302180 | NHSA |
| Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 国药准字H20233922 | 75mg | Category B | XN02BGP112E001010302297 | NHSA |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20203641 | 75mg | Category B | XN02BGP112E001010304565 | NHSA |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20253180 | 75mg | Category B | XN02BGP112E001010304606 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20213765 | 75mg | Category B | XN02BGP112E001010304647 | NHSA |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | 国药准字H20223712 | 75mg | Category B | XN02BGP112E001010304658 | NHSA |
| Upjohn EESV | 国药准字HJ20150620 | 75mg | Category B | XN02BGP112E001010378724 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213703 | 25mg | Category B | XN02BGP112E001010379261 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20243261 | 150mg | Category B | XN02BGP112E001010379286 | NHSA |
| Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized | 国药准字H20233167 | 75mg | Category B | XN02BGP112E001010381274 | NHSA |
| Hua Run Shuang He Pharma Co., Ltd. romanized | 国药准字H20203550 | 75mg | Category B | XN02BGP112E001010381661 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243211 | 75mg | Category B | XN02BGP112E001010383521 | NHSA |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20203641 | 75mg | Category B | XN02BGP112E001010404565 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20213765 | 75mg | Category B | XN02BGP112E001010404647 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213703 | 25mg | Category B | XN02BGP112E001010479261 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20243261 | 150mg | Category B | XN02BGP112E001010479286 | NHSA |
| Hua Run Shuang He Pharma Co., Ltd. romanized | 国药准字H20203550 | 75mg | Category B | XN02BGP112E001010481661 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243211 | 75mg | Category B | XN02BGP112E001010483521 | NHSA |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20203641 | 75mg | Category B | XN02BGP112E001010504565 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213703 | 25mg | Category B | XN02BGP112E001010579261 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20243261 | 150mg | Category B | XN02BGP112E001010579286 | NHSA |
| Hua Run Shuang He Pharma Co., Ltd. romanized | 国药准字H20203550 | 75mg | Category B | XN02BGP112E001010581661 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243211 | 75mg | Category B | XN02BGP112E001010583521 | NHSA |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20203641 | 75mg | Category B | XN02BGP112E001010604565 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20243261 | 150mg | Category B | XN02BGP112E001010679286 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243211 | 75mg | Category B | XN02BGP112E001010683521 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20243261 | 150mg | Category B | XN02BGP112E001010779286 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243211 | 75mg | Category B | XN02BGP112E001010783521 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20243261 | 150mg | Category B | XN02BGP112E001010879286 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243211 | 75mg | Category B | XN02BGP112E001010883521 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20243261 | 150mg | Category B | XN02BGP112E001010979286 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20243261 | 150mg | Category B | XN02BGP112E001011079286 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20243261 | 150mg | Category B | XN02BGP112E001011179286 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20243261 | 150mg | Category B | XN02BGP112E001011279286 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20243261 | 150mg | Category B | XN02BGP112E001011379286 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20243261 | 150mg | Category B | XN02BGP112E001011479286 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20243261 | 150mg | Category B | XN02BGP112E001011579286 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20243261 | 150mg | Category B | XN02BGP112E001011679286 | NHSA |
| Chongqing Sai Wei Pharma Co., Ltd. romanized | 国药准字H20130065 | 25mg | Category B | XN02BGP112E001020101028 | NHSA |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H20233558 | 150mg | Category B | XN02BGP112E001020101066 | NHSA |
| Upjohn EESV | 国药准字J20160021 | 75mg | Category B | XN02BGP112E001020101187 | NHSA |
| Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized | 国药准字H20223587 | 150mg | Category B | XN02BGP112E001020101748 | NHSA |
| Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 国药准字H20233923 | 150mg | Category B | XN02BGP112E001020102297 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20213450 | 150mg | Category B | XN02BGP112E001020102770 | NHSA |
| Ya Bao Pharma Group Co., Ltd. romanized | 国药准字H20223958 | 150mg | Category B | XN02BGP112E001020102987 | NHSA |
| Shandong Dan Hong Pharmaceutical Co., Ltd. romanized | 国药准字H20234017 | 150mg | Category B | XN02BGP112E001020104073 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20243977 | 75mg | Category B | XN02BGP112E001020104187 | NHSA |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20203640 | 150mg | Category B | XN02BGP112E001020104565 | NHSA |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20253179 | 150mg | Category B | XN02BGP112E001020104606 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20213766 | 100mg | Category B | XN02BGP112E001020104647 | NHSA |
| Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized | 国药准字H20223713 | 100mg | Category B | XN02BGP112E001020104658 | NHSA |
| Ao Mei Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20243329 | 75mg | Category B | XN02BGP112E001020105760 | NHSA |
| Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20203041 | 150mg | Category B | XN02BGP112E001020105847 | NHSA |
| Dr.Reddy's Laboratories Limited | 国药准字HJ20230098 | 150mg | Category B | XN02BGP112E001020178377 | NHSA |
| Upjohn EESV | 国药准字HJ20150623 | 150mg | Category B | XN02BGP112E001020178724 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213702 | 50mg | Category B | XN02BGP112E001020179261 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20247280 | 75mg | Category B | XN02BGP112E001020179286 | NHSA |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20223306 | 150mg | Category B | XN02BGP112E001020180086 | NHSA |
| Da Tong Pharmaceutical (Zhongguo) Co., Ltd. romanized | 国药准字H20253195 | 150mg | Category B | XN02BGP112E001020180685 | NHSA |
| Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized | 国药准字H20233166 | 100mg | Category B | XN02BGP112E001020181274 | NHSA |
| Hua Run Shuang He Pharma Co., Ltd. romanized | 国药准字H20203551 | 150mg | Category B | XN02BGP112E001020181661 | NHSA |
| Hainan Wan Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20213340 | 150mg | Category B | XN02BGP112E001020182249 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20243210 | 100mg | Category B | XN02BGP112E001020183521 | NHSA |
| Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanized | 国药准字H20249116 | 150mg | Category B | XN02BGP112E001020183544 | NHSA |
| Ningbo Shuang Cheng Pharma Co., Ltd. romanized | 国药准字H20243331 | 300mg | Category B | XN02BGP112E001020184155 | NHSA |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H20233558 | 150mg | Category B | XN02BGP112E001020201066 | NHSA |
| Upjohn EESV | 国药准字J20160021 | 75mg | Category B | XN02BGP112E001020201187 | NHSA |
| Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized | 国药准字H20223587 | 150mg | Category B | XN02BGP112E001020201748 | NHSA |
| Ya Bao Pharma Group Co., Ltd. romanized | 国药准字H20223958 | 150mg | Category B | XN02BGP112E001020202987 | NHSA |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20203640 | 150mg | Category B | XN02BGP112E001020204565 | NHSA |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20253179 | 150mg | Category B | XN02BGP112E001020204606 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20213766 | 100mg | Category B | XN02BGP112E001020204647 | NHSA |
| Ao Mei Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20243329 | 75mg | Category B | XN02BGP112E001020205760 | NHSA |
| Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20203041 | 150mg | Category B | XN02BGP112E001020205847 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213702 | 50mg | Category B | XN02BGP112E001020279261 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20247280 | 75mg | Category B | XN02BGP112E001020279286 | NHSA |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20223306 | 150mg | Category B | XN02BGP112E001020280086 | NHSA |
| Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized | 国药准字H20233166 | 100mg | Category B | XN02BGP112E001020281274 | NHSA |
| Hua Run Shuang He Pharma Co., Ltd. romanized | 国药准字H20203551 | 150mg | Category B | XN02BGP112E001020281661 | NHSA |
| Hainan Wan Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20213340 | 150mg | Category B | XN02BGP112E001020282249 | NHSA |
| Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanized | 国药准字H20249116 | 150mg | Category B | XN02BGP112E001020283544 | NHSA |
| Hunan Dong Ting Pharma Co., Ltd. romanized | 国药准字H20233558 | 150mg | Category B | XN02BGP112E001020301066 | NHSA |
| Upjohn EESV | 国药准字J20160021 | 75mg | Category B | XN02BGP112E001020301187 | NHSA |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20203640 | 150mg | Category B | XN02BGP112E001020304565 | NHSA |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20253179 | 150mg | Category B | XN02BGP112E001020304606 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20213766 | 100mg | Category B | XN02BGP112E001020304647 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213702 | 50mg | Category B | XN02BGP112E001020379261 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20247280 | 75mg | Category B | XN02BGP112E001020379286 | NHSA |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20223306 | 150mg | Category B | XN02BGP112E001020380086 | NHSA |
| Hua Run Shuang He Pharma Co., Ltd. romanized | 国药准字H20203551 | 150mg | Category B | XN02BGP112E001020381661 | NHSA |
| Hainan Wan Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20213340 | 150mg | Category B | XN02BGP112E001020382249 | NHSA |
| Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanized | 国药准字H20249116 | 150mg | Category B | XN02BGP112E001020383544 | NHSA |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20203640 | 150mg | Category B | XN02BGP112E001020404565 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20213766 | 100mg | Category B | XN02BGP112E001020404647 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213702 | 50mg | Category B | XN02BGP112E001020479261 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20247280 | 75mg | Category B | XN02BGP112E001020479286 | NHSA |
| Hainan Wan Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20213340 | 150mg | Category B | XN02BGP112E001020482249 | NHSA |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20203640 | 150mg | Category B | XN02BGP112E001020504565 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213702 | 50mg | Category B | XN02BGP112E001020579261 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20247280 | 75mg | Category B | XN02BGP112E001020579286 | NHSA |
| Hainan Wan Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20213340 | 150mg | Category B | XN02BGP112E001020582249 | NHSA |
| Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 国药准字H20203640 | 150mg | Category B | XN02BGP112E001020604565 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20247280 | 75mg | Category B | XN02BGP112E001020679286 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20247280 | 75mg | Category B | XN02BGP112E001020779286 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20247280 | 75mg | Category B | XN02BGP112E001020879286 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20247280 | 75mg | Category B | XN02BGP112E001020979286 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20247280 | 75mg | Category B | XN02BGP112E001021079286 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20247280 | 75mg | Category B | XN02BGP112E001021179286 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20247280 | 75mg | Category B | XN02BGP112E001021279286 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20247280 | 75mg | Category B | XN02BGP112E001021379286 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20247280 | 75mg | Category B | XN02BGP112E001021479286 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20247280 | 75mg | Category B | XN02BGP112E001021579286 | NHSA |
| Hunan Bao Bao Tuan Pharma Co., Ltd. romanized | 国药准字H20247280 | 75mg | Category B | XN02BGP112E001021679286 | NHSA |
| Chongqing Sai Wei Pharma Co., Ltd. romanized | 国药准字H20130073 | 75mg | Category B | XN02BGP112E001030101028 | NHSA |
| Upjohn EESV | 国药准字J20160022 | 150mg | Category B | XN02BGP112E001030101187 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20213767 | 150mg | Category B | XN02BGP112E001030104647 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213704 | 75mg | Category B | XN02BGP112E001030179261 | NHSA |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20223307 | 300mg | Category B | XN02BGP112E001030180086 | NHSA |
| Hainan Wan Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20213339 | 75mg | Category B | XN02BGP112E001030182249 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001030183521 | NHSA |
| Chongqing Sai Wei Pharma Co., Ltd. romanized | 国药准字H20130073 | 75mg | Category B | XN02BGP112E001030201028 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20213767 | 150mg | Category B | XN02BGP112E001030204647 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213704 | 75mg | Category B | XN02BGP112E001030279261 | NHSA |
| Hainan Wan Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20213339 | 75mg | Category B | XN02BGP112E001030282249 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001030283521 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20213767 | 150mg | Category B | XN02BGP112E001030304647 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213704 | 75mg | Category B | XN02BGP112E001030379261 | NHSA |
| Hainan Wan Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20213339 | 75mg | Category B | XN02BGP112E001030382249 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001030383521 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213704 | 75mg | Category B | XN02BGP112E001030479261 | NHSA |
| Hainan Wan Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20213339 | 75mg | Category B | XN02BGP112E001030482249 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001030483521 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213704 | 75mg | Category B | XN02BGP112E001030579261 | NHSA |
| Hainan Wan Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20213339 | 75mg | Category B | XN02BGP112E001030582249 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001030583521 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213704 | 75mg | Category B | XN02BGP112E001030679261 | NHSA |
| Hainan Wan Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20213339 | 75mg | Category B | XN02BGP112E001030682249 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001030683521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001030783521 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213704 | 75mg | Category B | XN02BGP112E001030879261 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001030883521 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213704 | 75mg | Category B | XN02BGP112E001030979261 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001030983521 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213704 | 75mg | Category B | XN02BGP112E001031079261 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001031083521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001031183521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001031283521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001031383521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001031483521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001031583521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001031683521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001031783521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001031883521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001031983521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001032083521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001032183521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001032283521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001032383521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001032483521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001032583521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20234482 | 150mg | Category B | XN02BGP112E001032683521 | NHSA |
| Chongqing Sai Wei Pharma Co., Ltd. romanized | 国药准字H20130073 | 75mg | Category B | XN02BGP112E001040101028 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213705 | 100mg | Category B | XN02BGP112E001040179261 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213705 | 100mg | Category B | XN02BGP112E001040279261 | NHSA |
| Chongqing Sai Wei Pharma Co., Ltd. romanized | 国药准字H20130073 | 75mg | Category B | XN02BGP112E001040301028 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213705 | 100mg | Category B | XN02BGP112E001040379261 | NHSA |
| Chongqing Sai Wei Pharma Co., Ltd. romanized | 国药准字H20130073 | 75mg | Category B | XN02BGP112E001040401028 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213705 | 100mg | Category B | XN02BGP112E001040479261 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213705 | 100mg | Category B | XN02BGP112E001040579261 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213706 | 150mg | Category B | XN02BGP112E001050179261 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213706 | 150mg | Category B | XN02BGP112E001050279261 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213706 | 150mg | Category B | XN02BGP112E001050379261 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213706 | 150mg | Category B | XN02BGP112E001050479261 | NHSA |
| Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | 国药准字H20213706 | 150mg | Category B | XN02BGP112E001050579261 | NHSA |
Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.
Loaded records: 12 filings and 6 distinct first applicants.
Generic 11 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHS2504260 | Generic | 2025/12/11 | Not stated by source | CDE |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHS2504259 | Generic | 2025/12/11 | Not stated by source | CDE |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHS2504258 | Generic | 2025/12/11 | Not stated by source | CDE |
| Sichuan Pharmaceutical Formulations Co., Ltd. romanized | CYHB2600369 | Supplement | 2026/02/24 | Not stated by source | CDE |
| Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized | CYHS2600422 | Generic | 2026/02/10 | Not stated by source | CDE |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | CYHS2504522 | Generic | 2026/01/01 | Not stated by source | CDE |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | CYHS2504521 | Generic | 2026/01/01 | Not stated by source | CDE |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | CYHS2504520 | Generic | 2026/01/01 | Not stated by source | CDE |
| CISEN PHARMACEUTICAL CO., LTD. | CYHS2503818 | Generic | 2025/10/29 | Not stated by source | CDE |
| CISEN PHARMACEUTICAL CO., LTD. | CYHS2503817 | Generic | 2025/10/29 | Not stated by source | CDE |
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | CYHS2502144 | Generic | 2025/06/17 | Not stated by source | CDE |
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | CYHS2502143 | Generic | 2025/06/17 | Not stated by source | CDE |
Loaded records: 4 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Chengdu Heng Rui Pharmaceutical Co., Ltd. romanized | CYHS2600422 | Generic | 2026/02/10 | Not stated by source | CDE |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | CYHS2504522 | Generic | 2026/01/01 | Not stated by source | CDE |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | CYHS2504521 | Generic | 2026/01/01 | Not stated by source | CDE |
| Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | CYHS2504520 | Generic | 2026/01/01 | Not stated by source | CDE |
Non-component matches: 25 companies with A status and 9 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 普瑞巴林 · No verified English name | Anhui Ding Wang Pharmaceuticals Co., Ltd. romanized | Y20260000861 | I | Exact ingredient | 2026/10/26 | CDE |
| 普瑞巴林 · No verified English name | Zhejiang Zhu Zi Pharmaceutical Co., Ltd. romanized | Y20260000563 | I | Exact ingredient | 2026/07/16 | CDE |
| 普瑞巴林 · No verified English name | Wan Yang Heng Shui Pharmaceutical Co., Ltd. romanized | Y20250001306 | I | Exact ingredient | 2025/12/04 | CDE |
| 普瑞巴林 · No verified English name | Shandong Li Xin Pharmaceutical Co., Ltd. romanized | Y20250000894 | I | Exact ingredient | 2025/09/30 | CDE |
| 普瑞巴林 · No verified English name | Zhejiang Pu Luo Jia Yuan Pharma Co., Ltd. romanized | Y20250000865 | I | Exact ingredient | 2025/09/03 | CDE |
| 普瑞巴林 · No verified English name | MSN Pharmachem Private Limited | Y20240000210 | A | Exact ingredient | 2026/05/20 | CDE |
| 普瑞巴林 · No verified English name | Upjohn EESV | Y20230001164 | A | Exact ingredient | 2025/12/29 | CDE |
| 普瑞巴林 · No verified English name | Shuang He Pharma (Shang Qiu) Co., Ltd. romanized | Y20230000632 | A | Exact ingredient | 2025/04/07 | CDE |
| 普瑞巴林 · No verified English name | Hikal Limited | Y20220000761 | A | Exact ingredient | 2025/04/22 | CDE |
| 普瑞巴林 · No verified English name | Shandong Li Xin Pharmaceutical Co., Ltd. romanized | Y20220000631 | I | Exact ingredient | 2022/09/08 | CDE |
| 普瑞巴林 · No verified English name | Vasudha Pharma Chem Limited | Y20210000819 | I | Exact ingredient | 2021/12/21 | CDE |
| 普瑞巴林 · No verified English name | Hunan Sai Long Pharma Co., Ltd. romanized | Y20210000955 | A | Exact ingredient | 2024/03/07 | CDE |
| 普瑞巴林 · No verified English name | Dong Bei Pharmaceutical Group Co., Ltd. romanized | Y20210000638 | A | Exact ingredient | 2024/01/24 | CDE |
| 普瑞巴林 · No verified English name | MSN Life Sciences Private Limited Unit - III romanized | Y20200001043 | A | Exact ingredient | 2025/08/16 | CDE |
| 普瑞巴林 · No verified English name | Divi’s Laboratories Limited | Y20210000256 | A | Exact ingredient | 2024/01/17 | CDE |
| 普瑞巴林 · No verified English name | Dr.Reddy‘s Laboratories Limited | Y20210000101 | I | Exact ingredient | 2023/12/20 | CDE |
| 普瑞巴林 · No verified English name | DR. REDDYS LABORATORIES LIMITED | Y20200000823 | A | Exact ingredient | 2026/07/11 | CDE |
| 普瑞巴林 · No verified English name | Jiangsu Hui Ju Pharma Co., Ltd. romanized | Y20190000654 | A | Exact ingredient | 2026/04/24 | CDE |
| 普瑞巴林 · No verified English name | CSPC OUYI PHARMACEUTICAL CO., LTD. | Y20190021404 | A | Exact ingredient | 2026/03/17 | CDE |
| 普瑞巴林 · No verified English name | Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | Y20190021315 | A | Exact ingredient | 2026/04/20 | CDE |
| 普瑞巴林 · No verified English name | Chongqing Sai Wei Pharma Co., Ltd. romanized | Y20190009848 | A | Exact ingredient | — | CDE |
| 普瑞巴林 · No verified English name | Chongqing Sai Wei Pharma Co., Ltd. romanized | Y20190000198 | A | Exact ingredient | 2025/09/25 | CDE |
| 普瑞巴林 · No verified English name | Ao Rui Te Pharma Co., Ltd. romanized | Y20190000368 | A | Exact ingredient | 2026/08/14 | CDE |
| 普瑞巴林 · No verified English name | Zhejiang Tian Yu Pharma Co., Ltd. romanized | Y20180001381 | A | Exact ingredient | 2026/01/13 | CDE |
| 普瑞巴林 · No verified English name | Zhejiang Mei Nuo Hua Drug Chemical Co., Ltd. romanized | Y20180001513 | A | Exact ingredient | 2025/07/18 | CDE |
| 普瑞巴林 · No verified English name | Jiangsu En Hua Pharma Co., Ltd. romanized | Y20170001560 | A | Exact ingredient | 2023/07/14 | CDE |
| 普瑞巴林 · No verified English name | Shuang He Pharma (Shang Qiu) Co., Ltd. romanized | Y20170001559 | A | Exact ingredient | 2023/05/11 | CDE |
| 普瑞巴林 · No verified English name | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20170001497 | A | Exact ingredient | 2023/08/16 | CDE |
| 普瑞巴林 · No verified English name | Guo Yao Group Yi Bin Pharmaceutical Co., Ltd. romanized | Y20170001200 | A | Exact ingredient | 2024/04/26 | CDE |
| 普瑞巴林 · No verified English name | Hetero Drugs Limited, Unit- IX | Y20170001183 | A | Exact ingredient | 2025/12/06 | CDE |
| 普瑞巴林 · No verified English name | Lang Fang Gao Bo Jing Bang Pharmaceutical Co., Ltd. romanized | Y20170001167 | A | Exact ingredient | 2022/09/08 | CDE |
| 普瑞巴林 · No verified English name | Optimus Drugs Pvt Ltd | Y20170001044 | I | Exact ingredient | — | CDE |
| 普瑞巴林 · No verified English name | SUN PHARMACEUTICAL INDUSTRIES LTD | Y20170000832 | A | Exact ingredient | 2022/09/05 | CDE |
| 普瑞巴林 · No verified English name | Shandong An Hong Pharmaceutical Co., Ltd. romanized | Y20170000821 | A | Exact ingredient | 2026/10/30 | CDE |
| 普瑞巴林 · No verified English name | Alembic Pharmaceuticals Ltd. | Y20170000779 | A | Exact ingredient | 2026/03/19 | CDE |
| 普瑞巴林 · No verified English name | CTX Lifesciences Pvt. Ltd. | Y20170000558 | A | Exact ingredient | 2026/08/22 | CDE |
A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.
Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately.
Trial registration does not mean an application will follow.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.
CYHB2601685
Fact date: 2026/09/04 · Site observation date: 2026/10/22
View source ↗CYHB2601684
Fact date: 2026/09/04 · Site observation date: 2026/10/22
View source ↗Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.
First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.
Daily collection reads new registrations. Backfill covers registration numbers from 2025 onward (CTR2025/CTR2026), not first-publication years. States are dated observations; revisions are not tracked.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
Public-product searches scanned: 7/30; discovered pending details: 13. Record counts in unscanned portions remain unknown.
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.
Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.
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