Monthly
US$200
Billed every month
Sign in to subscribeBetahistine Dihydrochloride Tablets
As of 13 November 2026, for Betahistine Dihydrochloride Tablets, 11 applications are listed as under review at China's CDE; 3 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 6 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 3 applications
Current coverage may be incomplete
Which companies are listed, and at what stages?
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.
Catalogue holders6View records ↓
Under-review filings11View records ↓
This year’s generic filers3View records ↓
NHSA approval numbers27View records ↓
API companies with A status18View records ↓
Chemical-drug catalogue
Loaded records: 6 holders; 4 in the quality-and-efficacy consistency-evaluation category, and 2 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 |
|---|---|---|---|---|---|---|
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20265152 | 2026/07/14 | 4mg | Generic approved under the new chemical-drug registration classification | CDE |
| Sen Miao (Shandong) Pharma Co., Ltd. romanized | Jinan Yong Ning Pharmaceutical Co., Ltd. romanized | 国药准字H20269094 | 2026/04/21 | 4mg | Generic approved under the new chemical-drug registration classification | CDE |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H20269089 | 2026/04/13 | 8mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H20113283 | 2026/04/13 | 4mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20263834 | 2026/04/07 | 8mg | Generic approved under the new chemical-drug registration classification | CDE |
| Topfond Pharmaceutical Co., Ltd. | Topfond Pharmaceutical Co., Ltd. | 国药准字H20247121 | 2024/06/05 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Topfond Pharmaceutical Co., Ltd. | Topfond Pharmaceutical Co., Ltd. | 国药准字H41023572 | 2024/06/05 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Sen Miao (Shandong) Pharma Co., Ltd. romanized | Jinan Yong Ning Pharmaceutical Co., Ltd. romanized | 国药准字H20243912 | 2024/06/04 | 8mg | Generic approved under the new chemical-drug registration classification | CDE |
| Le Pu Heng Jiu Yuan Pharma Co., Ltd. romanized | Le Pu Heng Jiu Yuan Pharma Co., Ltd. romanized | 国药准字H20205045 | 2022/02/25 | 8mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Henan Zhong Jie Pharma Co., Ltd. romanized | Henan Zhong Jie Pharma Co., Ltd. romanized | 国药准字H20217112 | 2021/11/15 | 8mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Henan Zhong Jie Pharma Co., Ltd. romanized | Henan Zhong Jie Pharma Co., Ltd. romanized | 国药准字H41023380 | 2021/11/15 | 4mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Le Pu Heng Jiu Yuan Pharma Co., Ltd. romanized | Le Pu Heng Jiu Yuan Pharma Co., Ltd. romanized | 国药准字H41022374 | 2020/11/16 | 4mg | Drug that passed quality-and-efficacy consistency evaluation | 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.
NHSA drug codes
Loaded records: 27 distinct approval numbers and 16 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Hua Run Zi Zhu Pharma Co., Ltd. romanized | 国药准字H11020414 | 4mg | Category A | XN07CAB046A001010100225 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20263834 | 8mg | Category A | XN07CAB046A001010100698 | NHSA |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H50020381 | 4mg | Category A | XN07CAB046A001010101016 | NHSA |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H41023572 | See source | Category A | XN07CAB046A001010103098 | NHSA |
| Le Pu Heng Jiu Yuan Pharma Co., Ltd. romanized | 国药准字H20205045 | 8mg | Category A | XN07CAB046A001010103212 | NHSA |
| Le Pu Heng Jiu Yuan Pharma Co., Ltd. romanized | 国药准字H41022374 | 4mg | Category A | XN07CAB046A001010103213 | NHSA |
| Henan Zhong Jie Pharma Co., Ltd. romanized | 国药准字H41023380 | 4mg | Category A | XN07CAB046A001010103227 | NHSA |
| Jilin Wan Tong Pharma Group Zhengzhou Wan Tong Fu Sheng Pharma Co., Ltd. romanized | 国药准字H41025663 | 4mg | Category A | XN07CAB046A001010103250 | NHSA |
| Shandong Li Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H37022879 | 5mg | Category A | XN07CAB046A001010103987 | NHSA |
| Xing Hui Tian Li (Hangzhou) Pharma Co., Ltd. romanized | 国药准字H33020459 | 5mg | Category A | XN07CAB046A001010104506 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H20113283 | 4mg | Category A | XN07CAB046A001010106644 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H20269089 | 8mg | Category A | XN07CAB046A001010183481 | NHSA |
| Shandong Li Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20243912 | 8mg | Category A | XN07CAB046A001010184029 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20263834 | 8mg | Category A | XN07CAB046A001010200698 | NHSA |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H50020381 | 4mg | Category A | XN07CAB046A001010201016 | NHSA |
| Yuan Yan Yao Gang Biopharmaceutical (Shenyang) Co., Ltd. romanized | 国药准字H21020945 | 4mg | Category A | XN07CAB046A001010201304 | NHSA |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H41023572 | See source | Category A | XN07CAB046A001010203098 | NHSA |
| Le Pu Heng Jiu Yuan Pharma Co., Ltd. romanized | 国药准字H20205045 | 8mg | Category A | XN07CAB046A001010203212 | NHSA |
| Le Pu Heng Jiu Yuan Pharma Co., Ltd. romanized | 国药准字H41022374 | 4mg | Category A | XN07CAB046A001010203213 | NHSA |
| Henan Zhong Jie Pharma Co., Ltd. romanized | 国药准字H41023380 | 4mg | Category A | XN07CAB046A001010203227 | NHSA |
| Jilin Wan Tong Pharma Group Zhengzhou Wan Tong Fu Sheng Pharma Co., Ltd. romanized | 国药准字H41025663 | 4mg | Category A | XN07CAB046A001010203250 | NHSA |
| Shandong Li Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H37022879 | 5mg | Category A | XN07CAB046A001010203987 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H20113283 | 4mg | Category A | XN07CAB046A001010206644 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H20269089 | 8mg | Category A | XN07CAB046A001010283481 | NHSA |
| Shandong Li Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20243912 | 8mg | Category A | XN07CAB046A001010284029 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20263834 | 8mg | Category A | XN07CAB046A001010300698 | NHSA |
| Yuan Yan Yao Gang Biopharmaceutical (Shenyang) Co., Ltd. romanized | 国药准字H21020945 | 4mg | Category A | XN07CAB046A001010301304 | NHSA |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H41023572 | See source | Category A | XN07CAB046A001010303098 | NHSA |
| Le Pu Heng Jiu Yuan Pharma Co., Ltd. romanized | 国药准字H20205045 | 8mg | Category A | XN07CAB046A001010303212 | NHSA |
| Le Pu Heng Jiu Yuan Pharma Co., Ltd. romanized | 国药准字H41022374 | 4mg | Category A | XN07CAB046A001010303213 | NHSA |
| Henan Zhong Jie Pharma Co., Ltd. romanized | 国药准字H41023380 | 4mg | Category A | XN07CAB046A001010303227 | NHSA |
| Jilin Wan Tong Pharma Group Zhengzhou Wan Tong Fu Sheng Pharma Co., Ltd. romanized | 国药准字H41025663 | 4mg | Category A | XN07CAB046A001010303250 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H20113283 | 4mg | Category A | XN07CAB046A001010306644 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H20269089 | 8mg | Category A | XN07CAB046A001010383481 | NHSA |
| Shandong Li Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20243912 | 8mg | Category A | XN07CAB046A001010384029 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20263834 | 8mg | Category A | XN07CAB046A001010400698 | NHSA |
| Yuan Yan Yao Gang Biopharmaceutical (Shenyang) Co., Ltd. romanized | 国药准字H21020945 | 4mg | Category A | XN07CAB046A001010401304 | NHSA |
| Le Pu Heng Jiu Yuan Pharma Co., Ltd. romanized | 国药准字H20205045 | 8mg | Category A | XN07CAB046A001010403212 | NHSA |
| Le Pu Heng Jiu Yuan Pharma Co., Ltd. romanized | 国药准字H41022374 | 4mg | Category A | XN07CAB046A001010403213 | NHSA |
| Henan Zhong Jie Pharma Co., Ltd. romanized | 国药准字H41023380 | 4mg | Category A | XN07CAB046A001010403227 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H20113283 | 4mg | Category A | XN07CAB046A001010406644 | NHSA |
| Shandong Li Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20243912 | 8mg | Category A | XN07CAB046A001010484029 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20263834 | 8mg | Category A | XN07CAB046A001010500698 | NHSA |
| Yuan Yan Yao Gang Biopharmaceutical (Shenyang) Co., Ltd. romanized | 国药准字H21020945 | 4mg | Category A | XN07CAB046A001010501304 | NHSA |
| Le Pu Heng Jiu Yuan Pharma Co., Ltd. romanized | 国药准字H41022374 | 4mg | Category A | XN07CAB046A001010503213 | NHSA |
| Henan Zhong Jie Pharma Co., Ltd. romanized | 国药准字H41023380 | 4mg | Category A | XN07CAB046A001010503227 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H20113283 | 4mg | Category A | XN07CAB046A001010506644 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20263834 | 8mg | Category A | XN07CAB046A001010600698 | NHSA |
| Henan Zhong Jie Pharma Co., Ltd. romanized | 国药准字H41023380 | 4mg | Category A | XN07CAB046A001010603227 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H20113283 | 4mg | Category A | XN07CAB046A001010606644 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20263834 | 8mg | Category A | XN07CAB046A001010700698 | NHSA |
| Henan Zhong Jie Pharma Co., Ltd. romanized | 国药准字H41023380 | 4mg | Category A | XN07CAB046A001010703227 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H20113283 | 4mg | Category A | XN07CAB046A001010706644 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20263834 | 8mg | Category A | XN07CAB046A001010800698 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H20113283 | 4mg | Category A | XN07CAB046A001010806644 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20263834 | 8mg | Category A | XN07CAB046A001010900698 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H20113283 | 4mg | Category A | XN07CAB046A001010906644 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20263834 | 8mg | Category A | XN07CAB046A001011000698 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H20113283 | 4mg | Category A | XN07CAB046A001011006644 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20263834 | 8mg | Category A | XN07CAB046A001011100698 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20265152 | 4mg | Category A | XN07CAB046A001020100698 | NHSA |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H50020381 | 4mg | Category A | XN07CAB046A001020101016 | NHSA |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H20247121 | See source | Category A | XN07CAB046A001020103098 | NHSA |
| Henan Zhong Jie Pharma Co., Ltd. romanized | 国药准字H20217112 | 8mg | Category A | XN07CAB046A001020103227 | NHSA |
| Shandong Li Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H37022879 | 5mg | Category A | XN07CAB046A001020103987 | NHSA |
| Shandong Li Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20269094 | 4mg | Category A | XN07CAB046A001020184029 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20265152 | 4mg | Category A | XN07CAB046A001020200698 | NHSA |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H20247121 | See source | Category A | XN07CAB046A001020203098 | NHSA |
| Henan Zhong Jie Pharma Co., Ltd. romanized | 国药准字H20217112 | 8mg | Category A | XN07CAB046A001020203227 | NHSA |
| Shandong Li Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20269094 | 4mg | Category A | XN07CAB046A001020284029 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20265152 | 4mg | Category A | XN07CAB046A001020300698 | NHSA |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H50020381 | 4mg | Category A | XN07CAB046A001020301016 | NHSA |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H20247121 | See source | Category A | XN07CAB046A001020303098 | NHSA |
| Henan Zhong Jie Pharma Co., Ltd. romanized | 国药准字H20217112 | 8mg | Category A | XN07CAB046A001020303227 | NHSA |
| Shandong Li Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20269094 | 4mg | Category A | XN07CAB046A001020384029 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20265152 | 4mg | Category A | XN07CAB046A001020400698 | NHSA |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H50020381 | 4mg | Category A | XN07CAB046A001020401016 | NHSA |
| Henan Zhong Jie Pharma Co., Ltd. romanized | 国药准字H20217112 | 8mg | Category A | XN07CAB046A001020403227 | NHSA |
| Shandong Li Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20269094 | 4mg | Category A | XN07CAB046A001020484029 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20265152 | 4mg | Category A | XN07CAB046A001020500698 | NHSA |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H50020381 | 4mg | Category A | XN07CAB046A001020501016 | NHSA |
| Henan Zhong Jie Pharma Co., Ltd. romanized | 国药准字H20217112 | 8mg | Category A | XN07CAB046A001020503227 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20265152 | 4mg | Category A | XN07CAB046A001020600698 | NHSA |
| Henan Zhong Jie Pharma Co., Ltd. romanized | 国药准字H20217112 | 8mg | Category A | XN07CAB046A001020603227 | NHSA |
| Henan Zhong Jie Pharma Co., Ltd. romanized | 国药准字H20217112 | 8mg | Category A | XN07CAB046A001020703227 | NHSA |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H50020380 | 5mg | Category A | XN07CAB046A001030101016 | NHSA |
| Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized | 国药准字H31022080 | 4mg | Category A | XN07CAB046A017010100818 | NHSA |
| Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H23020159 | 5mg | Category A | XN07CAB046A017010103754 | NHSA |
| Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized | 国药准字H31022080 | 4mg | Category A | XN07CAB046A017010200818 | NHSA |
| Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H23020159 | 5mg | Category A | XN07CAB046A017010203754 | NHSA |
| Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H23020159 | 5mg | Category A | XN07CAB046A017010303754 | NHSA |
| Guangdong Bang Min Pharmaceutical Factory Co., Ltd. romanized | 国药准字H44022849 | 5mg | Category A | XN07CAB046A018010100267 | NHSA |
| Shanghai Zhong Xi San Wei Pharma Co., Ltd. romanized | 国药准字H31020866 | 4mg | Category A | XN07CAB046A018010100748 | NHSA |
| Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized | 国药准字H31022080 | 4mg | Category A | XN07CAB046A018010100818 | NHSA |
| Zhengzhou Pu Ji Tang Pharma Co., Ltd. romanized | 国药准字H23021801 | 4mg | Category A | XN07CAB046A018010103620 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H23023161 | 5mg | Category A | XN07CAB046A018010103748 | NHSA |
| Zhengzhou Pu Ji Tang Pharma Co., Ltd. romanized | 国药准字H23021801 | 4mg | Category A | XN07CAB046A018010203620 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H23023161 | 5mg | Category A | XN07CAB046A018010203748 | NHSA |
| Zhengzhou Pu Ji Tang Pharma Co., Ltd. romanized | 国药准字H23021801 | 4mg | Category A | XN07CAB046A018010303620 | NHSA |
| Zhengzhou Pu Ji Tang Pharma Co., Ltd. romanized | 国药准字H23021801 | 4mg | Category A | XN07CAB046A018010403620 | NHSA |
| Zhengzhou Pu Ji Tang Pharma Co., Ltd. romanized | 国药准字H23021801 | 4mg | Category A | XN07CAB046A018010503620 | NHSA |
| Zhengzhou Pu Ji Tang Pharma Co., Ltd. romanized | 国药准字H23021801 | 4mg | Category A | XN07CAB046A018010603620 | NHSA |
| Guangdong Bang Min Pharmaceutical Factory Co., Ltd. romanized | 国药准字H44022848 | 10mg | Category A | XN07CAB046A018020100267 | NHSA |
| Zhengzhou Pu Ji Tang Pharma Co., Ltd. romanized | 国药准字H23021802 | 5mg | Category A | XN07CAB046A018020103620 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H23023161 | 5mg | Category A | XN07CAB046A018020103748 | NHSA |
| Zhengzhou Pu Ji Tang Pharma Co., Ltd. romanized | 国药准字H23021802 | 5mg | Category A | XN07CAB046A018020203620 | NHSA |
| Zhengzhou Pu Ji Tang Pharma Co., Ltd. romanized | 国药准字H23021802 | 5mg | Category A | XN07CAB046A018020303620 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H23023161 | 5mg | Category A | XN07CAB046A018020303748 | NHSA |
| Zhengzhou Pu Ji Tang Pharma Co., Ltd. romanized | 国药准字H23021802 | 5mg | Category A | XN07CAB046A018020403620 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H23023161 | 5mg | Category A | XN07CAB046A018020403748 | NHSA |
| Zhengzhou Pu Ji Tang Pharma Co., Ltd. romanized | 国药准字H23021802 | 5mg | Category A | XN07CAB046A018020503620 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H23023161 | 5mg | Category A | XN07CAB046A018020503748 | NHSA |
| Zhengzhou Pu Ji Tang Pharma Co., Ltd. romanized | 国药准字H23021802 | 5mg | Category A | XN07CAB046A018020603620 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H23023161 | 5mg | Category A | XN07CAB046A018020603748 | NHSA |
| Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized | 国药准字H23023161 | 5mg | Category A | XN07CAB046A018020703748 | 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.
Current under-review applications
Loaded records: 11 filings and 6 distinct first applicants.
Generic 7 · Supplement 4
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized; Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2602528 | Generic | 2026/10/14 | Not stated by source | CDE |
| Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized; Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2602527 | Generic | 2026/10/14 | Not stated by source | CDE |
| Le Pu Heng Jiu Yuan Pharma Co., Ltd. romanized | CYHB2601172 | Supplement | 2026/06/23 | Not stated by source | CDE |
| Le Pu Heng Jiu Yuan Pharma Co., Ltd. romanized | CYHB2601171 | Supplement | 2026/06/23 | Not stated by source | CDE |
| Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | CYHS2600388 | Generic | 2026/02/06 | Not stated by source | CDE |
| Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | CYHS2600387 | Generic | 2026/02/06 | Not stated by source | CDE |
| Shanghai Zhong Xi San Wei Pharma Co., Ltd. romanized; Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized | CYHB2550416 | Supplement | 2025/12/31 | Not stated by source | CDE |
| Shanghai Zhong Xi San Wei Pharma Co., Ltd. romanized; Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized | CYHB2550415 | Supplement | 2025/12/31 | Not stated by source | CDE |
| Anhui Hai Tian Xin Heng Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized | CYHS2503221 | Generic | 2025/09/02 | Not stated by source | CDE |
| Anhui Hai Tian Xin Heng Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized | CYHS2503220 | Generic | 2025/09/02 | Not stated by source | CDE |
| Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd. | CYHS2602608 | Generic | 2026/10/23 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 5 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized; Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2602528 | Generic | 2026/10/14 | Not stated by source | CDE |
| Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized; Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2602527 | Generic | 2026/10/14 | Not stated by source | CDE |
| Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | CYHS2600388 | Generic | 2026/02/06 | Not stated by source | CDE |
| Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | CYHS2600387 | Generic | 2026/02/06 | Not stated by source | CDE |
| Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd. | CYHS2602608 | Generic | 2026/10/23 | Not stated by source | CDE |
API registrations
Non-component matches: 18 companies with A status and 2 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 |
|---|---|---|---|---|---|---|
| 甲磺酸倍他司汀 · No verified English name | Run Dou Pharmaceutical (Jing Men) Co., Ltd. romanized | Y20250000941 | I | Salt-normalized ingredient | 2025/12/09 | CDE |
| 甲磺酸倍他司汀 · No verified English name | Anhui Ai Li De Pharmaceutical Co., Ltd. romanized | Y20250000838 | I | Salt-normalized ingredient | 2025/08/20 | CDE |
| 甲磺酸倍他司汀 · No verified English name | Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | Y20240000850 | A | Salt-normalized ingredient | 2026/01/05 | CDE |
| 甲磺酸倍他司汀 · No verified English name | Bai Yun Shandong Tai Shang Qiu Pharma Co., Ltd. romanized | Y20240000824 | A | Salt-normalized ingredient | 2026/01/05 | CDE |
| 甲磺酸倍他司汀 · No verified English name | Henan Pu Rui Pharmaceutical Co., Ltd. romanized | Y20240000139 | A | Salt-normalized ingredient | 2025/07/11 | CDE |
| 甲磺酸倍他司汀 · No verified English name | APICHEM Laboratories Private Limited, Unit-III | Y20230000819 | A | Salt-normalized ingredient | 2026/03/22 | CDE |
| 甲磺酸倍他司汀 · No verified English name | Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | Y20230000146 | A | Salt-normalized ingredient | 2024/12/13 | CDE |
| 盐酸倍他司汀 · No verified English name | Hebei Guo Long Pharmaceutical Co., Ltd. romanized | Y20230000179 | A | Exact ingredient | 2026/10/20 | CDE |
| 甲磺酸倍他司汀 · No verified English name | Hebei Guo Long Pharmaceutical Co., Ltd. romanized | Y20220001251 | A | Salt-normalized ingredient | 2026/09/02 | CDE |
| 盐酸倍他司汀 · No verified English name | Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | Y20220001031 | A | Exact ingredient | 2025/10/30 | CDE |
| 盐酸倍他司汀 · No verified English name | Laboratorios Espinos Y Bofill S.A.（Lebsa） | Y20200001475 | A | Exact ingredient | 2024/01/28 | CDE |
| 盐酸倍他司汀 · No verified English name | Guo Yao Group Guo Rui Pharma Co., Ltd. romanized | Y20200001402 | A | Exact ingredient | 2025/03/04 | CDE |
| 盐酸倍他司汀 · No verified English name | COHANCE LIFESCIENCES LIMITED | Y20200000965 | A | Exact ingredient | 2025/03/09 | CDE |
| 盐酸倍他司汀 · No verified English name | Zhejiang Le Pu Pharma Co., Ltd. romanized | Y20200001060 | A | Exact ingredient | 2025/12/31 | CDE |
| 甲磺酸倍他司汀 · No verified English name | Tokuyama Corporation | Y20190009122 | A | Salt-normalized ingredient | 2024/10/29 | CDE |
| 盐酸倍他司汀 · No verified English name | Jin Zhou Jiu Tai Pharma Co., Ltd. romanized | Y20190003821 | A | Exact ingredient | 2025/05/13 | CDE |
| 盐酸倍他司汀 · No verified English name | Shanghai Zhong Xi San Wei Pharma Co., Ltd. romanized | Y20190002829 | A | Exact ingredient | 2025/03/04 | CDE |
| 甲磺酸倍他司汀 · No verified English name | Guangdong Shi Xin Pharma Co., Ltd. romanized | Y20190001636 | A | Salt-normalized ingredient | 2024/12/14 | CDE |
| 盐酸倍他司汀 · No verified English name | Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized | Y20170001176 | A | Exact ingredient | 2026/01/01 | CDE |
| 盐酸倍他司汀 · No verified English name | AMI LIFESCIENCES PVT. LTD. | Y20170001070 | A | Exact ingredient | 2025/04/28 | CDE |
| 甲磺酸倍他司汀 · No verified English name | Xiamen En Cheng Pharmaceutical Co., Ltd. romanized | Y20170000962 | A | Salt-normalized ingredient | 2024/04/02 | CDE |
| 盐酸倍他司汀 · No verified English name | Henan Pu Rui Pharmaceutical Co., Ltd. romanized | Y20170000885 | A | Exact ingredient | 2024/09/11 | CDE |
| 盐酸倍他司汀 · No verified English name | APICHEM Laboratories Private Limited | Y20170000391 | A | Exact ingredient | 2025/11/14 | 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.
What changed recently?
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.
-
2026/11/03Marketing application approved
Jin Zhou Jiu Tai Pharma Co., Ltd. romanized
CYHS2501601 · 国药准字H20266491
Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.
View source · Table row 58 ↗ -
2026/10/23Accepted
Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd.
CYHS2602608
Fact date: 2026/10/23 · Site observation date: 2026/10/24
View source ↗ -
2026/10/14Accepted
Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized; Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized
CYHS2602528
Fact date: 2026/10/14 · Site observation date: 2026/10/22
View source ↗ -
2026/10/14Accepted
Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized; Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized
CYHS2602527
Fact date: 2026/10/14 · Site observation date: 2026/10/22
View source ↗
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/13 06:42
- Chemical-drug catalogue
- Last successful update: 2026/11/13 06:39
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.
- Full API register
- Last successful update: 2026/11/13 06:41
- NHSA drug codes
- Last successful update: 2026/11/05 06:45
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.
- NMPA drug delivery notices
- Last successful update: 2026/11/12 18:32 · Current coverage may be incomplete
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.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/13 08:09 · Current coverage may be incomplete
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.
Free follow
Follow changes to Betahistine Dihydrochloride Tablets
Up to 3 drugs per email address, in one weekly digest. Starts after email confirmation; unsubscribe at any time.
Subscriptions
Next-day facts and deliverable timelines
- One email the next day when new facts are collected for your followed products.
- 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.
Billed by Creem, our merchant of record · Terms · Refund policy