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Dolutegravir Sodium Tablets(多替拉韦钠片)
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 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 holders6View records ↓
Under-review filings3View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers7View records ↓
API companies with A status9View records ↓
Chemical-drug catalogue
Loaded records: 6 holders; 0 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 |
|---|---|---|---|---|---|---|
| 奥锐特药业股份有限公司 | 江苏和晨药业有限公司 | 国药准字H20264225 | 2026/05/07 | 50mg（以C20H19F2N3O5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 |
| 江苏艾迪药业集团股份有限公司 | 江苏艾迪药业集团股份有限公司 | 国药准字H20263536 | 2026/03/10 | 50mg（以C20H19F2N3O5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 |
| Hetero Labs Limited | Hetero Labs Limited | 国药准字HJ20260023 | 2026/02/10 | 50mg（按C20H19F2N3O5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 |
| 上海迪赛诺医药集团股份有限公司 | 上海迪赛诺医药集团股份有限公司 | 国药准字H20255617 | 2025/09/30 | 50mg（按C20H19F2N3O5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 |
| 齐鲁制药有限公司 | 齐鲁制药有限公司 | 国药准字H20234126 | 2023/09/05 | 50mg（以多替拉韦计） | 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 |
| 安徽贝克生物制药有限公司 | 安徽贝克生物制药有限公司 | 国药准字H20266322 | 2026/10/20 | 50mg（按C20H19F2N3O5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 |
|---|---|---|---|---|---|
| 齐鲁制药有限公司 | 国药准字H20234126 | 50mg(以多替拉韦计) | Not stated by source | XJ05AXD255A001010104021 | NHSA |
| 上海迪赛诺医药集团股份有限公司 | 国药准字H20255617 | 50mg(按C₂₀H₁₉F₂N₃O₅计) | Not stated by source | XJ05AXD255A001010105821 | NHSA |
| 奥锐特药业股份有限公司 | 国药准字H20264225 | 50mg(以C₂₀H₁₉F₂N₃O₅计) | Not stated by source | XJ05AXD255A001010108121 | NHSA |
| Hetero Labs Limited | 国药准字HJ20260023 | 50mg(按C₂₀H₁₉F₂N₃O₅计) | Not stated by source | XJ05AXD255A001010179426 | NHSA |
| ViiV Healthcare UK Limited | H20150683 | 50mg(以多替拉韦计) | Not stated by source | XJ05AXD255A001010179474 | NHSA |
| 江苏艾迪药业集团股份有限公司 | 国药准字H20263536 | 50mg(以C₂₀H₁₉F₂N₃O₅计) | Not stated by source | XJ05AXD255A001010181452 | NHSA |
| ViiV Healthcare B.V. | 国药准字HJ20150683 | 50mg(按C₂₀H₁₉F₂N₃O₅计) | Not stated by source | XJ05AXD255A001010279474 | 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 3 distinct first applicants.
Generic 2 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 东北制药集团沈阳第一制药有限公司 | CYHS2602412 | Generic | 2026/09/24 | Not stated by source | CDE |
| 成都倍特药业股份有限公司 | CYHS2601019 | Generic | 2026/04/30 | Not stated by source | CDE |
| ViiV Healthcare B.V.;Delpharm Poznan S.A | JYHB2500595 | Supplement | 2025/11/06 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 9 companies with A status and 3 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 |
|---|---|---|---|---|---|---|
| 多替拉韦钠 | 东北制药集团股份有限公司 | Y20260000543 | I | Exact ingredient | 2026/07/01 | CDE |
| 多替拉韦钠 | Laurus Labs Limited | Y20250000916 | I | Exact ingredient | 2025/09/18 | CDE |
| 多替拉韦钠 | 四川仁安药业有限责任公司 | Y20250000207 | A | Exact ingredient | 2026/07/27 | CDE |
| 多替拉韦钠 | 安徽贝克制药股份有限公司 | Y20240001543 | A | Exact ingredient | 2026/07/02 | CDE |
| 多替拉韦钠 | 东北制药集团股份有限公司 | Y20240001408 | I | Exact ingredient | 2024/12/20 | CDE |
| 多替拉韦钠 | 重庆凯林制药有限公司 | Y20240000649 | A | Exact ingredient | 2026/03/20 | CDE |
| 多替拉韦钠 | 重庆博腾制药科技股份有限公司 | Y20240000525 | A | Exact ingredient | 2026/02/13 | CDE |
| 多替拉韦钠 | 扬州艾迪医药科技有限公司 | Y20240000542 | A | Exact ingredient | 2025/10/27 | CDE |
| 多替拉韦钠 | 上海迪赛诺化学制药有限公司 | Y20240000231 | A | Exact ingredient | 2025/09/17 | CDE |
| 多替拉韦钠 | 石家庄龙泽制药股份有限公司 | Y20240000162 | A | Exact ingredient | 2025/11/14 | CDE |
| 多替拉韦钠 | 扬州奥锐特药业有限公司 | Y20230001397 | A | Exact ingredient | 2026/05/15 | CDE |
| 多替拉韦钠 | 山东安弘制药有限公司 | Y20220000041 | A | Exact ingredient | 2023/09/14 | 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: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
-
2026/10/20Marketing application approved
安徽贝克生物制药有限公司
CYHS2501764 · 国药准字H20266322
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
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 65 ↗ -
2026/09/24Accepted
东北制药集团沈阳第一制药有限公司
CYHS2602412
Fact date: 2026/09/24 · Site observation date: 2026/10/22
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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