Monthly
US$200
Billed every month
Ondansetron Hydrochloride Tablets(盐酸昂丹司琼片)
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 holders5View records ↓
Under-review filings6View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers11View records ↓
API companies with A status13View records ↓
Chemical-drug catalogue
Loaded records: 5 holders; 3 in the quality-and-efficacy consistency-evaluation category, and 2 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 |
|---|---|---|---|---|---|---|
| 北大医药股份有限公司 | 北大医药股份有限公司 | 国药准字H10970155 | 2025/04/11 | 4mg(以C18H19N3O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 |
| 杭州和泽坤元药业有限公司 | 宁波美诺华天康药业有限公司 | 国药准字H20249199 | 2024/10/29 | 8mg（按C18H19N3O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 |
| 杭州和泽坤元药业有限公司 | 宁波美诺华天康药业有限公司 | 国药准字H20249200 | 2024/10/29 | 4mg（按C18H19N3O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H20234368 | 2023/10/24 | 按C18H19N3O计 8mg | 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H20234369 | 2023/10/24 | 按C18H19N3O计 4mg | 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 |
| 福安药业集团宁波天衡制药有限公司 | 福安药业集团宁波天衡制药有限公司 | 国药准字H10960146 | 2023/02/20 | 4mg(按C18H19N3O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 |
| 齐鲁制药有限公司 | 齐鲁制药有限公司 | 国药准字H10970062 | 2019/12/10 | 4mg（按C18H19N3O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 |
| 齐鲁制药有限公司 | 齐鲁制药有限公司 | 国药准字H10970063 | 2019/01/16 | 8mg（按C18H19N3O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 |
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 7 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 成都通德药业有限公司 | 国药准字H20263083 | 8mg(按C₁₈H₁₉N₃O计) | Category A (甲) | XA04AAA202A001010102068 | NHSA |
| 成都通德药业有限公司 | 国药准字H20263083 | 8mg(按C₁₈H₁₉N₃O计) | Category A (甲) | XA04AAA202A001010202068 | NHSA |
| 杭州沐源生物医药科技股份有限公司 | 国药准字H20254887 | 8mg(按C₁₈H₁₉N₃O计) | Category A (甲) | XA04AAA202A001010184135 | NHSA |
| 杭州沐源生物医药科技股份有限公司 | 国药准字H20254888 | 4mg(按C₁₈H₁₉N₃O计) | Category A (甲) | XA04AAA202A001020184135 | NHSA |
| 北大医药股份有限公司 | 国药准字H10970155 | 4mg(以C₁₈H₁₉N₃O计) | Category A (甲) | XA04AAA202A001010100976 | NHSA |
| 石家庄四药有限公司 | 国药准字H20234368 | 按C₁₈H₁₉N₃O计 8mg | Category A (甲) | XA04AAA202A001010102763 | NHSA |
| 齐鲁制药有限公司 | 国药准字H10970062 | 4mg(按C₁₈H₁₉N₃O计) | Category A (甲) | XA04AAA202A001010104021 | NHSA |
| 福安药业集团宁波天衡制药有限公司 | 国药准字H10960146 | 4mg(按C18H19N3O计) | Category A (甲) | XA04AAA202A001010104561 | NHSA |
| 浙江皓格药业有限公司 | 国药准字H20249199 | 8mg(按C₁₈H₁₉N₃O计算) | Category A (甲) | XA04AAA202A001010184206 | NHSA |
| 北大医药股份有限公司 | 国药准字H10970155 | 4mg(以C₁₈H₁₉N₃O计) | Category A (甲) | XA04AAA202A001010200976 | NHSA |
| 福安药业集团宁波天衡制药有限公司 | 国药准字H10960146 | 4mg(按C18H19N3O计) | Category A (甲) | XA04AAA202A001010204561 | NHSA |
| 北大医药股份有限公司 | 国药准字H10970155 | 4mg(以C₁₈H₁₉N₃O计) | Category A (甲) | XA04AAA202A001020100976 | NHSA |
| 石家庄四药有限公司 | 国药准字H20234369 | 按C₁₈H₁₉N₃O计 4mg | Category A (甲) | XA04AAA202A001020102763 | NHSA |
| 浙江皓格药业有限公司 | 国药准字H20249200 | 4mg(按C₁₈H₁₉N₃O计算) | Category A (甲) | XA04AAA202A001020184206 | NHSA |
| 齐鲁制药有限公司 | 国药准字H10970063 | 8mg(按C₁₈H₁₉N₃O计) | Category A (甲) | XA04AAA202A001020204021 | NHSA |
| 北大医药股份有限公司 | 国药准字H10970155 | 4mg(以C₁₈H₁₉N₃O计) | Category A (甲) | XA04AAA202A001030100976 | NHSA |
| 石家庄四药有限公司 | 国药准字H20234368 | 按C₁₈H₁₉N₃O计 8mg | Category A (甲) | XA04AAA202A001030102763 | NHSA |
| 福安药业集团宁波天衡制药有限公司 | 国药准字H10960146 | 4mg(按C18H19N3O计) | Category A (甲) | XA04AAA202A001030104561 | NHSA |
| 石家庄四药有限公司 | 国药准字H20234369 | 按C₁₈H₁₉N₃O计 4mg | Category A (甲) | XA04AAA202A001040102763 | 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: 6 filings and 3 distinct first applicants.
Generic 6
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京海鲸药业股份有限公司 | CYHS2601877 | Generic | 2026/08/03 | Not stated by source | CDE |
| 南京海鲸药业股份有限公司 | CYHS2601876 | Generic | 2026/08/03 | Not stated by source | CDE |
| 四川依科制药有限公司 | CYHS2602450 | Generic | 2026/10/08 | Not stated by source | CDE |
| 四川依科制药有限公司 | CYHS2602449 | Generic | 2026/10/08 | Not stated by source | CDE |
| 辰欣药业股份有限公司 | CYHS2503243 | Generic | 2025/09/02 | Not stated by source | CDE |
| 辰欣药业股份有限公司 | CYHS2503242 | Generic | 2025/09/02 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 4 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京海鲸药业股份有限公司 | CYHS2601877 | Generic | 2026/08/03 | Not stated by source | CDE |
| 南京海鲸药业股份有限公司 | CYHS2601876 | Generic | 2026/08/03 | Not stated by source | CDE |
| 四川依科制药有限公司 | CYHS2602450 | Generic | 2026/10/08 | Not stated by source | CDE |
| 四川依科制药有限公司 | CYHS2602449 | Generic | 2026/10/08 | Not stated by source | CDE |
API registrations
Non-component matches: 13 companies with A status and 5 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 |
|---|---|---|---|---|---|---|
| 盐酸昂丹司琼 | 四川伊诺达博医药科技有限公司 | Y20250000969 | I | Exact ingredient | 2025/09/19 | CDE |
| 昂丹司琼 | 四川伊诺达博医药科技有限公司 | Y20250000968 | I | Salt-normalized ingredient | 2025/09/19 | CDE |
| 盐酸昂丹司琼 | 四川新开元制药有限公司 | Y20250000593 | A | Exact ingredient | 2026/10/16 | CDE |
| 昂丹司琼 | Shodhana Laboratories Private Limited | Y20250000166 | I | Salt-normalized ingredient | 2025/04/03 | CDE |
| 昂丹司琼 | HIKAL LIMITED | Y20230000886 | I | Salt-normalized ingredient | 2024/01/30 | CDE |
| 昂丹司琼 | 四川新开元制药有限公司 | Y20230000303 | A | Salt-normalized ingredient | 2026/06/16 | CDE |
| 昂丹司琼 | Dr. Reddy's Laboratories Ltd. | Y20220001178 | A | Salt-normalized ingredient | 2025/08/28 | CDE |
| 盐酸昂丹司琼 | 兰西哈三联制药有限公司 | Y20220000619 | A | Exact ingredient | 2025/05/09 | CDE |
| 盐酸昂丹司琼 | Apitoria Pharma Private Limited | Y20210000190 | A | Exact ingredient | 2025/07/15 | CDE |
| 盐酸昂丹司琼 | Natco Pharma Limited | Y20200000836 | A | Exact ingredient | 2024/01/31 | CDE |
| 盐酸昂丹司琼 | Dr. Reddy's Laboratories Ltd. | Y20200000931 | A | Exact ingredient | 2026/05/20 | CDE |
| 昂丹司琼 | 江苏恒瑞医药股份有限公司 | Y20190021613 | A | Salt-normalized ingredient | 2026/08/20 | CDE |
| 盐酸昂丹司琼 | 福安药业集团宁波天衡制药有限公司 | Y20190009491 | A | Exact ingredient | — | CDE |
| 盐酸昂丹司琼 | 四川川大华西药业股份有限公司 | Y20190006261 | A | Exact ingredient | — | CDE |
| 盐酸昂丹司琼 | 海南先声药业有限公司 | Y20190006208 | A | Exact ingredient | 2024/06/28 | CDE |
| 盐酸昂丹司琼 | 常州亚邦制药有限公司 | Y20190004948 | A | Exact ingredient | 2025/08/30 | CDE |
| 盐酸昂丹司琼 | 常州兰陵制药有限公司 | Y20190003744 | A | Exact ingredient | 2025/07/18 | CDE |
| 盐酸昂丹司琼 | 北大医药股份有限公司 | Y20190002237 | A | Exact ingredient | 2025/09/01 | CDE |
| 盐酸昂丹司琼 | 齐鲁制药有限公司 | Y20190001571 | A | Exact ingredient | 2024/11/21 | CDE |
| 盐酸昂丹司琼（工艺2） | 齐鲁制药有限公司 | Y20180001627 | I | Exact ingredient | 2019/02/03 | CDE |
| 盐酸昂丹司琼 | 齐鲁制药有限公司 | Y20180001049 | A | Exact ingredient | 2025/07/18 | CDE |
| 盐酸昂丹司琼 | 福安药业集团宁波天衡制药有限公司 | Y20170002166 | A | Exact ingredient | 2025/01/25 | 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.
-
2026/10/08Accepted
-
2026/10/08Accepted
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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