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Amiodarone Hydrochloride Tablets(盐酸胺碘酮片)
Companies, stages and changes, with each record available on this page.
No changes recorded by this site in the last 90 days
Complete CDE snapshot: 2026/11/10 07:27
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 filings3View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers17View records ↓
API companies with A status8View records ↓
Chemical-drug catalogue
Loaded records: 3 holders; 3 in the quality-and-efficacy consistency-evaluation category, and 0 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 |
|---|---|---|---|---|---|---|
| 上海上药信谊药厂有限公司 | 上海上药信谊药厂有限公司 | 国药准字H31021872 | 2022/02/14 | 0.2g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 山东信谊制药有限公司 | 山东信谊制药有限公司 | 国药准字H37021456 | 2020/09/25 | 0.2g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 宁波大红鹰药业股份有限公司 | 宁波大红鹰药业股份有限公司 | 国药准字H33020581 | 2020/05/11 | 0.2g | 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: 17 distinct approval numbers and 16 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 北京嘉林药业股份有限公司 | 国药准字H20003843 | 0.2g | Category A (甲) | XC01BDA201A001010100056 | NHSA |
| 广东彼迪药业有限公司 | 国药准字H44021623 | 0.2g | Category A (甲) | XC01BDA201A001010100269 | NHSA |
| 广东华南药业集团有限公司 | 国药准字H44020694 | 0.2g | Category A (甲) | XC01BDA201A001010100290 | NHSA |
| 三才石岐制药股份有限公司 | 国药准字H44023284 | 0.2g | Category A (甲) | XC01BDA201A001010100322 | NHSA |
| 广州白云山医药集团股份有限公司白云山制药总厂 | 国药准字H44025075 | 0.1g | Category A (甲) | XC01BDA201A001010100376 | NHSA |
| 上海上药信谊药厂有限公司 | 国药准字H31021872 | 0.2g | Category A (甲) | XC01BDA201A001010100818 | NHSA |
| 江苏涟水制药有限公司 | 国药准字H32022397 | 0.2g | Category A (甲) | XC01BDA201A001010101466 | NHSA |
| 金陵药业股份有限公司南京金陵制药厂 | 国药准字H32024405 | 0.2g | Category A (甲) | XC01BDA201A001010101529 | NHSA |
| 江苏悦兴药业有限公司 | 国药准字H32024766 | 0.2g | Category A (甲) | XC01BDA201A001010101631 | NHSA |
| 江苏恩华赛德药业有限责任公司 | 国药准字H32021922 | 0.2g | Category A (甲) | XC01BDA201A001010101721 | NHSA |
| 海南制药厂有限公司制药一厂 | 国药准字H41021027 | 0.2g | Category A (甲) | XC01BDA201A001010103012 | NHSA |
| 天方药业有限公司 | 国药准字H41021592 | 0.2g | Category A (甲) | XC01BDA201A001010103098 | NHSA |
| 山东信谊制药有限公司 | 国药准字H37021456 | 0.2g | Category A (甲) | XC01BDA201A001010104165 | NHSA |
| 赛诺菲(杭州)制药有限公司 | 国药准字H19993254 | 0.2g | Category A (甲) | XC01BDA201A001010104502 | NHSA |
| 杭州煌森生物科技有限公司 | 国药准字H33020581 | 0.2g | Category A (甲) | XC01BDA201A001010104554 | NHSA |
| Sanofi Winthrop Industrie | 国药准字HJ20181050 | 0.2g/片 | Category A (甲) | XC01BDA201A001010178821 | NHSA |
| 上海上药信谊药厂有限公司 | 国药准字H31021872 | 0.2g | Category A (甲) | XC01BDA201A001010200818 | NHSA |
| 海南制药厂有限公司制药一厂 | 国药准字H41021027 | 0.2g | Category A (甲) | XC01BDA201A001010203012 | NHSA |
| 山东信谊制药有限公司 | 国药准字H37021456 | 0.2g | Category A (甲) | XC01BDA201A001010204165 | NHSA |
| 杭州煌森生物科技有限公司 | 国药准字H33020581 | 0.2g | Category A (甲) | XC01BDA201A001010204554 | NHSA |
| 山东信谊制药有限公司 | 国药准字H37021456 | 0.2g | Category A (甲) | XC01BDA201A001010304165 | NHSA |
| 山东信谊制药有限公司 | 国药准字H37021456 | 0.2g | Category A (甲) | XC01BDA201A001010404165 | NHSA |
| 山东信谊制药有限公司 | 国药准字H37021456 | 0.2g | Category A (甲) | XC01BDA201A001010504165 | NHSA |
| 广州白云山医药集团股份有限公司白云山制药总厂 | 国药准字H44021436 | 0.2g | Category A (甲) | XC01BDA201A001020100376 | 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: 3 filings and 2 distinct first applicants.
Generic 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 上海理想制药有限公司 | CYHS2601549 | Generic | 2026/07/01 | Not stated by source | CDE |
| 上海理想制药有限公司 | CYHS2601548 | Generic | 2026/07/01 | Not stated by source | CDE |
| 珠海润都制药股份有限公司 | CYHS2600788 | Generic | 2026/04/08 | 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 |
|---|---|---|---|---|---|
| 上海理想制药有限公司 | CYHS2601549 | Generic | 2026/07/01 | Not stated by source | CDE |
| 上海理想制药有限公司 | CYHS2601548 | Generic | 2026/07/01 | Not stated by source | CDE |
| 珠海润都制药股份有限公司 | CYHS2600788 | Generic | 2026/04/08 | Not stated by source | CDE |
API registrations
Non-component matches: 8 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 |
|---|---|---|---|---|---|---|
| 盐酸胺碘酮 | 山东济坤生物制药有限公司 | Y20250000128 | I | Exact ingredient | 2025/02/07 | CDE |
| 盐酸胺碘酮 | 海南卓科制药有限公司 | Y20240000433 | A | Exact ingredient | 2026/04/21 | CDE |
| 盐酸胺碘酮 | 湖南复瑞生物医药技术有限责任公司 | Y20220001071 | A | Exact ingredient | 2026/08/28 | CDE |
| 盐酸胺碘酮 | 海南普利制药股份有限公司 | Y20210001090 | A | Exact ingredient | 2026/06/02 | CDE |
| 盐酸胺碘酮 | 山东方明药业集团股份有限公司 | Y20210000139 | A | Exact ingredient | 2023/08/26 | CDE |
| 盐酸胺碘酮 | Sanofi Chimie | Y20190009089 | A | Exact ingredient | 2025/03/25 | CDE |
| 盐酸胺碘酮 | 浙江恒康药业股份有限公司 | Y20190007055 | A | Exact ingredient | 2025/05/01 | CDE |
| 盐酸胺碘酮 | 山东信谊制药有限公司 | Y20190002029 | A | Exact ingredient | 2025/02/12 | CDE |
| 盐酸胺碘酮 | 山东北大高科华泰制药有限公司 | Y20190000397 | A | Exact ingredient | 2025/05/13 | CDE |
| 盐酸胺碘酮 | Sanofi Chimie | Y20180000626 | I | Exact ingredient | 2018/08/30 | 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.
- No matching records were found in the currently loaded source data; coverage dates are listed below.
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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