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Dronedarone Hydrochloride Tablets(盐酸决奈达隆片)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 2 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.
Company names, approval identifiers and strengths are retained as recorded in the Chinese sources. Category labels include the original wording for verification.
Catalogue holders8View records ↓
Under-review filings4View records ↓
This year’s generic filers3View records ↓
NHSA approval numbers7View records ↓
API companies with A status6View records ↓
Chemical-drug catalogue
Loaded records: 8 holders; 1 in the quality-and-efficacy consistency-evaluation category, and 6 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 |
|---|---|---|---|---|---|---|
| 齐鲁制药有限公司 | 齐鲁制药有限公司 | 国药准字H20254815 | 2025/07/08 | 400mg（按C31H44N2O5S计） | 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 |
| 石家庄四药有限公司 | 石家庄四药有限公司 | 国药准字H20254075 | 2025/05/13 | 400mg（按C31H44N2O5S计） | 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 |
| 江西科睿药业有限公司 | 江西科睿药业有限公司 | 国药准字H20253890 | 2025/04/15 | 400mg（按C31H44N2O5S计） | 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 |
| 山东新时代药业有限公司 | 山东新时代药业有限公司 | 国药准字H20253735 | 2025/03/25 | 400mg（按C31H44N2O5S计） | 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 |
| 江苏利泰尔药业有限公司 | 江苏利泰尔药业有限公司 | 国药准字H20243515 | 2024/04/17 | 400mg（按C31H44N2O5S计） | 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 |
| 石药集团欧意药业有限公司 | 石药集团欧意药业有限公司 | 国药准字H20193291 | 2022/11/10 | 400mg（以C31H44N2O5S计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| Sanofi-Aventis U.S., LLC | Sanofi Winthrop Industrie | 国药准字HJ20210084 | 2021/12/20 | 400 mg（按C31H44N2O5S计 ） | Imported originator drug (进口原研药品) | CDE |
| 安徽艾立德制药有限公司 | 安徽艾立德制药有限公司 | 国药准字H20264701 | 2026/06/10 | 400mg（按C31H44N2O5S计） | 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 |
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: 7 distinct approval numbers and 7 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 石家庄四药有限公司 | 国药准字H20254075 | 400mg(按C₃₁H₄₄N₂O₅S计) | Not stated by source | XC01BDJ205A001010102763 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20193291 | 400mg(以C31H44N205S计) | Not stated by source | XC01BDJ205A001010102770 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20254815 | 400mg(按C₃₁H₄₄N₂O₅S计) | Not stated by source | XC01BDJ205A001010104021 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20253735 | 400mg(按C₃₁H₄₄N₂O₅S计) | Not stated by source | XC01BDJ205A001010104188 | NHSA |
| 江苏利泰尔药业有限公司 | 国药准字H20243515 | 400mg(按C₃₁H₄₄N₂O₅S计) | Not stated by source | XC01BDJ205A001010182291 | NHSA |
| Sanofi Aventis U.S., LLC | 国药准字HJ20210084 | 400mg(按C31H44N2O5S计 ) | Not stated by source | XC01BDJ205A001010183961 | NHSA |
| 江西科睿药业有限公司 | 国药准字H20253890 | 400mg(按C₃₁H₄₄N₂O₅S计) | Not stated by source | XC01BDJ205A001010184736 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20193291 | 400mg(以C31H44N205S计) | Not stated by source | XC01BDJ205A001010202770 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20253735 | 400mg(按C₃₁H₄₄N₂O₅S计) | Not stated by source | XC01BDJ205A001010204188 | NHSA |
| Sanofi Aventis U.S., LLC | 国药准字HJ20210084 | 400mg(按C31H44N2O5S计 ) | Not stated by source | XC01BDJ205A001010283961 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20253735 | 400mg(按C₃₁H₄₄N₂O₅S计) | Not stated by source | XC01BDJ205A001010304188 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20253735 | 400mg(按C₃₁H₄₄N₂O₅S计) | Not stated by source | XC01BDJ205A001010404188 | 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: 4 filings and 4 distinct first applicants.
Generic 4
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 成都百裕制药股份有限公司;成都第一制药有限公司 | CYHS2602341 | Generic | 2026/09/20 | Not stated by source | CDE |
| 石家庄市华新药业有限责任公司 | CYHS2600036 | Generic | 2026/01/06 | Not stated by source | CDE |
| 南通慧聚制药有限公司 | CYHS2602585 | Generic | 2026/10/21 | Not stated by source | CDE |
| 浙江众延医药科技有限公司;青岛黄海制药有限责任公司 | CYHS2503637 | Generic | 2025/10/12 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 3 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 成都百裕制药股份有限公司;成都第一制药有限公司 | CYHS2602341 | Generic | 2026/09/20 | Not stated by source | CDE |
| 石家庄市华新药业有限责任公司 | CYHS2600036 | Generic | 2026/01/06 | Not stated by source | CDE |
| 南通慧聚制药有限公司 | CYHS2602585 | Generic | 2026/10/21 | Not stated by source | CDE |
API registrations
Non-component matches: 6 companies with A status and 1 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 |
|---|---|---|---|---|---|---|
| 盐酸决奈达隆 | 重庆瑞泊莱制药有限公司 | Y20250000798 | I | Exact ingredient | 2025/11/10 | CDE |
| 盐酸决奈达隆 | 安徽艾立德制药有限公司 | Y20240001285 | A | Exact ingredient | 2026/07/16 | CDE |
| 盐酸决奈达隆 | 山东新时代药业有限公司 | Y20240000678 | A | Exact ingredient | 2026/03/16 | CDE |
| 盐酸决奈达隆 | 河北国龙制药有限公司 | Y20230000733 | A | Exact ingredient | 2026/02/28 | CDE |
| 盐酸决奈达隆 | Aurore Pharmaceuticals Private Limited | Y20220000934 | A | Exact ingredient | 2026/06/09 | CDE |
| 盐酸决奈达隆 | 江苏慧聚药业股份有限公司 | Y20220000297 | A | Exact ingredient | 2025/09/26 | CDE |
| 盐酸决奈达隆 | 石药集团欧意药业有限公司 | Y20170001272 | A | Exact ingredient | 2026/03/11 | 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.
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2026/10/21Accepted
-
2026/09/20Accepted
成都百裕制药股份有限公司;成都第一制药有限公司
CYHS2602341
Fact date: 2026/09/20 · Site observation date: 2026/10/21
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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