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草酸艾司西酞普兰口服溶液
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 holders0View records ↓
Under-review filings11View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers11View records ↓
API companies with A status16View records ↓
Chemical-drug catalogue
Loaded records: 0 holders; 0 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 |
|---|---|---|---|---|---|---|
| No matching records were found in the currently loaded source data; coverage dates are listed below. | ||||||
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: 11 distinct approval numbers and 9 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 浙江国镜药业有限公司 | 国药准字H20233498 | 按C₂₀H₂₁FN₂O计:5ml:5mg | Category B (乙) | XN06ABA225X001010104634 | NHSA |
| Hetero Labs Limited | 国药准字HJ20240068 | 240ml:240mg(按C₂₀H₂₁FN₂O计) | Category B (乙) | XN06ABA225X001010179426 | NHSA |
| 海南广升誉制药有限公司 | 国药准字H20265587 | 120ml:120mg(按C₂₀H₂₁FN₂O计) | Category B (乙) | XN06ABA225X001010181251 | NHSA |
| 江苏长泰药业股份有限公司 | 国药准字H20255733 | 100ml:100mg(按C₂₀H₂₁FN₂O计) | Category B (乙) | XN06ABA225X001010181484 | NHSA |
| 成都康弘药业集团股份有限公司 | 国药准字H20223916 | 120ml:120mg(按C₂₀H₂₁FN₂O计) | Category B (乙) | XN06ABA225X001010181591 | NHSA |
| 成都倍特得诺药业有限公司 | 国药准字H20265851 | 按C₂₀H₂₁FN₂O计10ml:10mg | Category B (乙) | XN06ABA225X001010182338 | NHSA |
| 苏州朗科生物技术股份有限公司 | 国药准字H20253930 | 240ml:240mg(按C₂₀H₂₁FN₂O计) | Category B (乙) | XN06ABA225X001010183485 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20255582 | 10ml:10mg(按C₂₀H₂₁FN₂O计) | Category B (乙) | XN06ABA225X001010183595 | NHSA |
| 北京海步医药科技有限公司 | 国药准字H20254879 | 180ml:180mg(按C₂₀H₂₁FN₂O计) | Category B (乙) | XN06ABA225X001010183603 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20255582 | 10ml:10mg(按C₂₀H₂₁FN₂O计) | Category B (乙) | XN06ABA225X001010283595 | NHSA |
| 浙江国镜药业有限公司 | 国药准字H20233498 | 按C₂₀H₂₁FN₂O计:5ml:5mg | Category B (乙) | XN06ABA225X001010304634 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20255582 | 10ml:10mg(按C₂₀H₂₁FN₂O计) | Category B (乙) | XN06ABA225X001010383595 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20255582 | 10ml:10mg(按C₂₀H₂₁FN₂O计) | Category B (乙) | XN06ABA225X001010483595 | NHSA |
| 浙江国镜药业有限公司 | 国药准字H20233499 | 按C₂₀H₂₁FN₂O计:10ml:10mg | Category B (乙) | XN06ABA225X001020104634 | NHSA |
| 成都倍特得诺药业有限公司 | 国药准字H20265852 | 按C₂₀H₂₁FN₂O计240ml:240mg | Category B (乙) | XN06ABA225X001020182338 | NHSA |
| 浙江国镜药业有限公司 | 国药准字H20233499 | 按C₂₀H₂₁FN₂O计:10ml:10mg | Category B (乙) | XN06ABA225X001020304634 | 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: 11 filings and 9 distinct first applicants.
Generic 11
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 武汉益博元医药科技有限公司;江苏欧歌制药有限公司 | CYHS2502162 | Generic | 2025/06/17 | Not stated by source | CDE |
| 江苏贝佳制药有限公司 | CYHS2601596 | Generic | 2026/07/06 | Not stated by source | CDE |
| 常州四药制药有限公司 | CYHS2601486 | Generic | 2026/06/24 | Not stated by source | CDE |
| 山东百诺医药股份有限公司;吉林省西点药业科技发展股份有限公司 | CYHS2504440 | Generic | 2025/12/27 | Not stated by source | CDE |
| 哈尔滨市康隆药业有限责任公司 | CYHS2504337 | Generic | 2025/12/22 | Not stated by source | CDE |
| 哈尔滨市康隆药业有限责任公司 | CYHS2504336 | Generic | 2025/12/22 | Not stated by source | CDE |
| 哈尔滨市康隆药业有限责任公司 | CYHS2504335 | Generic | 2025/12/22 | Not stated by source | CDE |
| 西洲医药科技（浙江）有限公司;浙江北生药业汉生制药有限公司 | CYHS2503923 | Generic | 2025/11/12 | Not stated by source | CDE |
| 浙江杭康药业有限公司 | CYHS2503080 | Generic | 2025/08/22 | Not stated by source | CDE |
| 浙江领创优品药业有限公司;浙江赛默制药有限公司 | CYHS2502944 | Generic | 2025/08/13 | Not stated by source | CDE |
| 山东朗诺制药有限公司 | CYHS2501513 | Generic | 2025/04/22 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 16 companies with A status and 4 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 |
|---|---|---|---|---|---|---|
| 草酸艾司西酞普兰 | 上海锦帝九州药业（安阳）有限公司 | Y20260000777 | I | Exact ingredient | 2026/09/10 | CDE |
| 草酸艾司西酞普兰 | 湖北葛店人福药业有限责任公司 | Y20260000275 | I | Exact ingredient | 2026/04/29 | CDE |
| 草酸艾司西酞普兰 | Virupaksha Organics Limited | Y20240000675 | A | Exact ingredient | 2026/04/21 | CDE |
| 草酸艾司西酞普兰 | Hetero Labs Limited | Y20210001164 | A | Exact ingredient | 2024/12/29 | CDE |
| 草酸艾司西酞普兰 | 万全万特制药（厦门）有限公司 | Y20200000363 | I | Exact ingredient | 2020/05/15 | CDE |
| 草酸艾司西酞普兰 | Olon S.p.A. | Y20190021297 | A | Exact ingredient | 2022/10/27 | CDE |
| 草酸艾司西酞普兰 | 山东锐顺药业有限公司 | Y20190009855 | A | Exact ingredient | 2024/01/17 | CDE |
| 草酸艾司西酞普兰 | 浙江华海药业股份有限公司 | Y20190009839 | A | Exact ingredient | 2026/05/20 | CDE |
| 草酸艾司西酞普兰 | 四川科伦药业股份有限公司 | Y20190008922 | A | Exact ingredient | 2024/07/26 | CDE |
| 草酸艾司西酞普兰 | 山东安信制药有限公司 | Y20190008896 | A | Exact ingredient | 2024/04/30 | CDE |
| 草酸艾司西酞普兰 | 浙江海森药业股份有限公司 | Y20190007282 | A | Exact ingredient | 2023/08/16 | CDE |
| 草酸艾司西酞普兰 | 无锡积大制药有限公司 | Y20190006965 | A | Exact ingredient | 2023/03/24 | CDE |
| 草酸艾司西酞普兰 | 湖南洞庭药业股份有限公司 | Y20190001441 | A | Exact ingredient | 2024/10/18 | CDE |
| 草酸艾司西酞普兰 | 吉林省西点药业科技发展股份有限公司 | Y20190001382 | A | Exact ingredient | 2025/08/09 | CDE |
| 草酸艾司西酞普兰 | 浙江华海药业股份有限公司 | Y20180001104 | A | Exact ingredient | 2026/05/20 | CDE |
| 草酸艾司西酞普兰 | 山东锐顺药业有限公司 | Y20170001891 | A | Exact ingredient | 2024/09/26 | CDE |
| 草酸艾司西酞普兰 | 山东新华制药股份有限公司 | Y20170001449 | A | Exact ingredient | 2024/02/08 | CDE |
| 草酸艾司西酞普兰 | 上海现代制药股份有限公司 | Y20170001293 | A | Exact ingredient | 2024/01/18 | CDE |
| 草酸艾司西酞普兰 | 瑞阳制药股份有限公司 | Y20170001283 | A | Exact ingredient | 2025/01/03 | CDE |
| 草酸艾司西酞普兰 | 乳源东阳光药业有限公司 | Y20170000762 | A | Exact ingredient | 2023/08/10 | CDE |
| 草酸艾司西酞普兰 | 万全万特制药江苏有限公司 | Y20170000654 | A | Exact ingredient | 2023/03/24 | CDE |
| 草酸艾司西酞普兰 | 辰欣药业股份有限公司 | Y20170000637 | I | Exact ingredient | — | 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.
-
2026/11/05No longer listed under review
成都天之翼尚品医药科技有限公司;太极集团四川太极制药有限公司
CYHS2501528
Fact date: 2026/11/05 · Site observation date: 2026/11/05
Accepted: 2025/04/23
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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