Monthly
US$200
Billed every month
Diphenhydramine Hydrochloride Injection(盐酸苯海拉明注射液)
Companies, stages and changes, with each record available on this page.
Last 90 days: No longer listed under review: 1 application
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.
Company names, approval identifiers and strengths are retained as recorded in the Chinese sources. Category labels include the original wording for verification.
Catalogue holders3View records ↓
Under-review filings9View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers20View records ↓
API companies with A status18View records ↓
Chemical-drug catalogue
Loaded records: 3 holders; 2 in the quality-and-efficacy consistency-evaluation category, and 1 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 |
|---|---|---|---|---|---|---|
| 山东致泰医药技术有限公司 | 安徽恒星制药有限公司 | 国药准字H20263032 | 2026/01/05 | 1ml: 50mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 遂成药业股份有限公司 | 遂成药业股份有限公司 | 国药准字H20258253 | 2025/11/20 | 0.4ml：20mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 遂成药业股份有限公司 | 遂成药业股份有限公司 | 国药准字H20258254 | 2025/11/20 | 1ml：50mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 上海朝晖药业有限公司 | 上海朝晖药业有限公司 | 国药准字H20258139 | 2025/07/24 | 1ml：50mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | 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: 20 distinct approval numbers and 17 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 北京市永康药业有限公司 | 国药准字H11020523 | 1ml:20mg | Category A (甲) | XR06AAB058B002010100137 | NHSA |
| 广东邦民制药厂有限公司 | 国药准字H44021906 | 1ml:20mg | Category A (甲) | XR06AAB058B002010100267 | NHSA |
| 广州白云山明兴制药有限公司 | 国药准字H44022387 | 1ml:20mg | Category A (甲) | XR06AAB058B002010100375 | NHSA |
| 上海朝晖药业有限公司 | 国药准字H31021087 | 1ml:20mg | Category A (甲) | XR06AAB058B002010100665 | NHSA |
| 津药和平(天津)制药有限公司 | 国药准字H12020617 | 1ml:20mg | Category A (甲) | XR06AAB058B002010100874 | NHSA |
| 西南药业股份有限公司 | 国药准字H50020144 | 1ml:20mg | Category A (甲) | XR06AAB058B002010100978 | NHSA |
| 亚邦医药股份有限公司 | 国药准字H32021435 | 1ml:20mg | Category A (甲) | XR06AAB058B002010101511 | NHSA |
| 湖北科伦药业有限公司 | 国药准字H42021175 | 1ml:20mg | Category A (甲) | XR06AAB058B002010101871 | NHSA |
| 西安利君制药有限责任公司 | 国药准字H61021679 | 1ml:20mg | Category A (甲) | XR06AAB058B002010102503 | NHSA |
| 河北万成医药科技有限公司 | 国药准字H13021443 | 1ml:20mg | Category A (甲) | XR06AAB058B002010102598 | NHSA |
| 天方药业有限公司 | 国药准字H41020354 | 1ml:20mg | Category A (甲) | XR06AAB058B002010103098 | NHSA |
| 开封制药(集团)有限公司 | 国药准字H41021792 | 1ml:20mg | Category A (甲) | XR06AAB058B002010103139 | NHSA |
| 遂成药业股份有限公司 | 国药准字H41021264 | 1ml:20mg | Category A (甲) | XR06AAB058B002010103204 | NHSA |
| 新乡市常乐制药有限责任公司 | 国药准字H41020225 | 1ml:20mg | Category A (甲) | XR06AAB058B002010103216 | NHSA |
| 中嘉生物科技(湖北省)有限公司 | 国药准字H20053926 | 1ml:20mg | Category A (甲) | XR06AAB058B002010103377 | NHSA |
| 福建古田药业有限公司 | 国药准字H35020106 | 1ml:20mg | Category A (甲) | XR06AAB058B002010104770 | NHSA |
| 上海朝晖药业有限公司 | 国药准字H20258139 | 1ml:50mg | Category A (甲) | XR06AAB058B002010106917 | NHSA |
| 山东致泰医药技术有限公司 | 国药准字H20263032 | 1ml:50mg | Category A (甲) | XR06AAB058B002010183094 | NHSA |
| 北京市永康药业有限公司 | 国药准字H11020523 | 1ml:20mg | Category A (甲) | XR06AAB058B002010200137 | NHSA |
| 广州白云山明兴制药有限公司 | 国药准字H44022387 | 1ml:20mg | Category A (甲) | XR06AAB058B002010200375 | NHSA |
| 上海朝晖药业有限公司 | 国药准字H31021087 | 1ml:20mg | Category A (甲) | XR06AAB058B002010200665 | NHSA |
| 津药和平(天津)制药有限公司 | 国药准字H12020617 | 1ml:20mg | Category A (甲) | XR06AAB058B002010200874 | NHSA |
| 西南药业股份有限公司 | 国药准字H50020144 | 1ml:20mg | Category A (甲) | XR06AAB058B002010200978 | NHSA |
| 亚邦医药股份有限公司 | 国药准字H32021435 | 1ml:20mg | Category A (甲) | XR06AAB058B002010201511 | NHSA |
| 湖北科伦药业有限公司 | 国药准字H42021175 | 1ml:20mg | Category A (甲) | XR06AAB058B002010201871 | NHSA |
| 西安利君制药有限责任公司 | 国药准字H61021679 | 1ml:20mg | Category A (甲) | XR06AAB058B002010202503 | NHSA |
| 河北万成医药科技有限公司 | 国药准字H13021443 | 1ml:20mg | Category A (甲) | XR06AAB058B002010202598 | NHSA |
| 天方药业有限公司 | 国药准字H41020354 | 1ml:20mg | Category A (甲) | XR06AAB058B002010203098 | NHSA |
| 遂成药业股份有限公司 | 国药准字H41021264 | 1ml:20mg | Category A (甲) | XR06AAB058B002010203204 | NHSA |
| 新乡市常乐制药有限责任公司 | 国药准字H41020225 | 1ml:20mg | Category A (甲) | XR06AAB058B002010203216 | NHSA |
| 上海朝晖药业有限公司 | 国药准字H20258139 | 1ml:50mg | Category A (甲) | XR06AAB058B002010206917 | NHSA |
| 山东致泰医药技术有限公司 | 国药准字H20263032 | 1ml:50mg | Category A (甲) | XR06AAB058B002010283094 | NHSA |
| 遂成药业股份有限公司 | 国药准字H20258253 | 0.4ml:20mg | Category A (甲) | XR06AAB058B002020103204 | NHSA |
| 开封制药(集团)有限公司 | 国药准字H41021792 | 1ml:20mg | Category A (甲) | XR06AAB058B002020203139 | NHSA |
| 遂成药业股份有限公司 | 国药准字H20258253 | 0.4ml:20mg | Category A (甲) | XR06AAB058B002020203204 | NHSA |
| 遂成药业股份有限公司 | 国药准字H20258254 | 1ml:50mg | Category A (甲) | XR06AAB058B002030103204 | NHSA |
| 遂成药业股份有限公司 | 国药准字H20258254 | 1ml:50mg | Category A (甲) | XR06AAB058B002030203204 | 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: 9 filings and 6 distinct first applicants.
Generic 5 · Supplement 4
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏润恒制药有限公司 | CYHS2600837 | Generic | 2026/04/11 | Not stated by source | CDE |
| 江苏润恒制药有限公司 | CYHS2600836 | Generic | 2026/04/11 | Not stated by source | CDE |
| 安徽威尔曼制药有限公司 | CYHS2601497 | Generic | 2026/06/25 | Not stated by source | CDE |
| 武汉滨湖双鹤药业有限责任公司;武汉福星生物药业有限公司 | CYHB2650133 | Supplement | 2026/06/10 | Not stated by source | CDE |
| 新乡市常乐制药有限责任公司 | CYHB2650036 | Supplement | 2026/01/31 | Not stated by source | CDE |
| 新乡市常乐制药有限责任公司 | CYHB2650035 | Supplement | 2026/01/31 | Not stated by source | CDE |
| 新乡市常乐制药有限责任公司 | CYHB2650034 | Supplement | 2026/01/31 | Not stated by source | CDE |
| 广州瑞尔医药科技有限公司;峨眉山通惠制药有限公司 | CYHS2503744 | Generic | 2025/10/21 | Not stated by source | CDE |
| 四川天杏汇医药科技有限公司;成都百裕制药股份有限公司 | CYHS2503453 | Generic | 2025/09/18 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 3 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏润恒制药有限公司 | CYHS2600837 | Generic | 2026/04/11 | Not stated by source | CDE |
| 江苏润恒制药有限公司 | CYHS2600836 | Generic | 2026/04/11 | Not stated by source | CDE |
| 安徽威尔曼制药有限公司 | CYHS2601497 | Generic | 2026/06/25 | Not stated by source | CDE |
API registrations
Non-component matches: 18 companies with A status and 5 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 |
|---|---|---|---|---|---|---|
| 盐酸苯海拉明 | 浙江普洛康裕制药有限公司 | Y20260000429 | I | Exact ingredient | 2026/05/29 | CDE |
| 盐酸苯海拉明 | 连云港贵科药业有限公司 | Y20250001034 | I | Exact ingredient | 2025/10/13 | CDE |
| 盐酸苯海拉明 | 津药药业股份有限公司 | Y20240000952 | I | Exact ingredient | 2024/09/09 | CDE |
| 苯海拉明 | 金鸿药业股份有限公司 | Y20240000477 | A | Salt-normalized ingredient | 2025/09/30 | CDE |
| 盐酸苯海拉明 | 云鹏医药集团有限公司 | Y20240000441 | A | Exact ingredient | 2026/01/22 | CDE |
| 盐酸苯海拉明 | 长春海悦药业股份有限公司 | Y20240000223 | A | Exact ingredient | 2026/09/29 | CDE |
| 盐酸苯海拉明 | 安徽恒星制药有限公司 | Y20230001131 | A | Exact ingredient | 2025/03/25 | CDE |
| 枸橼酸苯海拉明 | 合肥恩瑞特药业有限公司 | Y20230001060 | I | Salt-normalized ingredient | 2023/11/24 | CDE |
| 盐酸苯海拉明 | 四川省玉鑫药业有限公司 | Y20230000805 | A | Exact ingredient | 2026/06/27 | CDE |
| 盐酸苯海拉明 | 白云山东泰商丘药业有限公司 | Y20230000405 | A | Exact ingredient | 2026/01/23 | CDE |
| 盐酸苯海拉明 | Supriya Lifescience Ltd. | Y20210001163 | A | Exact ingredient | 2025/09/28 | CDE |
| 盐酸苯海拉明 | 吉林省博大伟业制药有限公司 | Y20230000277 | A | Exact ingredient | 2024/10/29 | CDE |
| 枸橼酸苯海拉明 | 植恩生物技术股份有限公司 | Y20220001232 | A | Salt-normalized ingredient | 2026/02/26 | CDE |
| 盐酸苯海拉明 | 安徽威尔曼制药有限公司 | Y20210000548 | A | Exact ingredient | 2023/09/15 | CDE |
| 盐酸苯海拉明 | Wanbury Limited | Y20200000355 | A | Exact ingredient | 2026/06/13 | CDE |
| 苯海拉明 | Kongo Chemical Co., Ltd. | Y20200000683 | I | Salt-normalized ingredient | 2023/03/13 | CDE |
| 盐酸苯海拉明 | 上海朝晖药业有限公司 | Y20190007179 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸苯海拉明 | 上海上药新亚药业有限公司 | Y20190007095 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸苯海拉明 | 启东东岳药业有限公司 | Y20190006273 | A | Exact ingredient | 2026/01/08 | CDE |
| 盐酸苯海拉明 | 辽源市迪康药业有限责任公司 | Y20190005518 | A | Exact ingredient | 2025/05/07 | CDE |
| 盐酸苯海拉明 | 华润双鹤药业股份有限公司 | Y20190005444 | A | Exact ingredient | — | CDE |
| 盐酸苯海拉明 | 北京太洋药业股份有限公司 | Y20190004759 | A | Exact ingredient | 2025/04/23 | CDE |
| 盐酸苯海拉明 | 辽源市百康药业有限责任公司 | Y20190002144 | A | Exact ingredient | 2025/03/22 | 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.
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: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
-
2026/11/06No longer listed under review
安徽长江药业有限公司
CYHS2501704
Fact date: 2026/11/06 · Site observation date: 2026/11/06
Accepted: 2025/05/10
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/10 07:27
- Chemical-drug catalogue
- Last successful update: 2026/11/10 07:23
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: 2026/11/10 07:25
- 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: 2026/11/10 18:31
First index-page publication dates: 2026-10-26 to 2026-11-10; 0 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/10 08:10 · 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: 3/30; discovered pending details: 20. 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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