Monthly
US$200
Billed every month
琥珀酸地文拉法辛缓释片
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 holders3View records ↓
Under-review filings3View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers7View records ↓
API companies with A status5View records ↓
Chemical-drug catalogue
Loaded records: 3 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 3 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 |
|---|---|---|---|---|---|---|
| 扬子江药业集团有限公司 | 扬子江药业集团有限公司 | 国药准字H20263242 | 2026/01/27 | 50mg（以C16H25NO2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 |
| 扬子江药业集团有限公司 | 扬子江药业集团有限公司 | 国药准字H20263241 | 2026/01/27 | 100mg（按C16H25NO2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 |
| 宜昌人福药业有限责任公司 | 宜昌人福药业有限责任公司 | 国药准字H20253250 | 2025/01/24 | 按C16H25NO2计 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 |
| 宜昌人福药业有限责任公司 | 宜昌人福药业有限责任公司 | 国药准字H20253251 | 2025/01/24 | 按C16H25NO2计 100mg | 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 |
| 宜昌人福药业有限责任公司 | 宜昌人福药业有限责任公司 | 国药准字H20253249 | 2025/01/24 | 按C16H25NO2计 25mg | 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H20234594 | 2023/12/05 | 25mg（按C16H25NO2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H20233840 | 2023/06/30 | 50mg（按C16H25NO2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 3 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 扬子江药业集团有限公司 | 国药准字H20263242 | 50mg(以C₁₆H₂₅NO₂计) | Category B (乙) | XN06AXD371A010010101749 | NHSA |
| 宜昌人福药业有限责任公司 | 国药准字H20253249 | 按C16H25NO2计 25mg | Category B (乙) | XN06AXD371A010010102000 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20233840 | 50mg(按C₁₆H₂₅NO₂计) | Category B (乙) | XN06AXD371A010010102770 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20233840 | 50mg(按C₁₆H₂₅NO₂计) | Category B (乙) | XN06AXD371A010010202770 | NHSA |
| 扬子江药业集团有限公司 | 国药准字H20263241 | 100mg(按C₁₆H₂₅NO₂计) | Category B (乙) | XN06AXD371A010020101749 | NHSA |
| 宜昌人福药业有限责任公司 | 国药准字H20253250 | 按C16H25NO2计 50mg | Category B (乙) | XN06AXD371A010020102000 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20234594 | 25mg(按C₁₆H₂₅NO₂计) | Category B (乙) | XN06AXD371A010020102770 | NHSA |
| 宜昌人福药业有限责任公司 | 国药准字H20253251 | 按C16H25NO2计 100mg | Category B (乙) | XN06AXD371A010030102000 | 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 |
|---|---|---|---|---|---|
| 植恩生物技术股份有限公司 | CYHS2602120 | Generic | 2026/08/25 | Not stated by source | CDE |
| 植恩生物技术股份有限公司 | CYHS2602119 | Generic | 2026/08/25 | Not stated by source | CDE |
| 合肥华方医药科技有限公司;合肥思普瑞药业有限公司 | CYHS2601636 | Generic | 2026/07/08 | 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 |
|---|---|---|---|---|---|
| 植恩生物技术股份有限公司 | CYHS2602120 | Generic | 2026/08/25 | Not stated by source | CDE |
| 植恩生物技术股份有限公司 | CYHS2602119 | Generic | 2026/08/25 | Not stated by source | CDE |
| 合肥华方医药科技有限公司;合肥思普瑞药业有限公司 | CYHS2601636 | Generic | 2026/07/08 | Not stated by source | CDE |
API registrations
Non-component matches: 5 companies with A status and 0 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 |
|---|---|---|---|---|---|---|
| 琥珀酸地文拉法辛 | 浙江普洛家园药业有限公司 | Y20230000897 | A | Exact ingredient | 2025/11/04 | CDE |
| 琥珀酸地文拉法辛 | 植恩生物技术股份有限公司 | Y20230000468 | A | Exact ingredient | 2026/07/25 | CDE |
| 琥珀酸地文拉法辛 | 石药集团欧意药业有限公司 | Y20210001218 | A | Exact ingredient | 2026/02/26 | CDE |
| 琥珀酸地文拉法辛 | Alembic Pharmaceuticals Limited | Y20190000455 | A | Exact ingredient | 2025/05/29 | CDE |
| 琥珀酸地文拉法辛 | Megafine Pharma (P) Ltd． | Y20170001059 | A | Exact ingredient | 2026/09/05 | 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.
-
2026/08/25Accepted
-
2026/08/25Accepted
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.
Free follow
Follow changes to this drug
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
Yearly
US$1,920
Billed every year
US$160 per month
Online subscriptions are not enabled. The form below registers interest; it does not charge or activate access.
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.
US$490
One payment · 12 months of access
Online comparison-table purchase is not enabled.
Billed by Creem, our merchant of record · Terms · Refund policy