Monthly
US$200
Billed every month
Fluvastatin Sodium Extended Release Tablets(氟伐他汀钠缓释片)
Companies, stages and changes, with each record available on this page.
No changes recorded by this site in the last 90 days
Complete CDE snapshot: 2026/11/10 07:27
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 holders10View records ↓
Under-review filings6View records ↓
This year’s generic filers5View records ↓
NHSA approval numbers10View records ↓
API companies with A status9View records ↓
Chemical-drug catalogue
Loaded records: 10 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 9 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 |
|---|---|---|---|---|---|---|
| 北京四环科宝制药股份有限公司 | 北京四环科宝制药股份有限公司 | 国药准字H20265424 | 2026/07/28 | 80mg（按C24H26FNO4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 |
| 浙江高跖医药科技股份有限公司 | 浙江京新药业股份有限公司 | 国药准字H20265054 | 2026/06/30 | 80mg（按C24H26FNO4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 |
| 浙江昂利康制药股份有限公司 | 浙江昂利康制药股份有限公司 | 国药准字H20264495 | 2026/05/27 | 80mg（按C24H26FNO4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 |
| 浙江华海药业股份有限公司 | 浙江华海药业股份有限公司 | 国药准字H20264130 | 2026/04/21 | 80mg（按C24H26FNO4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 |
| 浙江普洛康裕制药有限公司 | 浙江普洛康裕制药有限公司 | 国药准字H20263882 | 2026/04/07 | 80mg（按C24H26FNO4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 |
| 杭州泓友医药科技有限公司 | 华益药业科技（安徽）有限公司 | 国药准字H20263287 | 2026/01/27 | 80mg（按C24H26FNO4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 |
| 南通联亚药业股份有限公司 | 南通联亚药业股份有限公司 | 国药准字H20255562 | 2025/09/23 | 80mg（按C24H26FNO4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 |
| 北京福元医药股份有限公司 | 北京福元医药股份有限公司 | 国药准字H20234643 | 2023/12/13 | 80mg（按C24H26FNO4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 |
| 北京世桥生物制药有限公司 | 北京世桥生物制药有限公司 | 国药准字H20213801 | 2021/10/26 | 80mg（按C24H26FNO4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 |
| — | 北京诺华制药有限公司 | 国药准字H20090179 | 2009/04/09 | 80mg | Other drug (其他药品) | 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: 10 distinct approval numbers and 10 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 北京诺华制药有限公司 | 国药准字H20090179 | 80mg | Category B (乙) | XC10AAF067A010010100100 | NHSA |
| 北京世桥生物制药有限公司 | 国药准字H20213801 | 80mg(按C24H26FNO4计) | Category B (乙) | XC10AAF067A010010100123 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20234643 | 80mg(按C24H26FNO4计) | Category B (乙) | XC10AAF067A010010100177 | NHSA |
| 浙江昂利康制药股份有限公司 | 国药准字H20264495 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010104606 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20264130 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010104647 | NHSA |
| 浙江普洛康裕制药有限公司 | 国药准字H20263882 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010104685 | NHSA |
| 南通联亚药业股份有限公司 | 国药准字H20255562 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010183802 | NHSA |
| 浙江高跖医药科技股份有限公司 | 国药准字H20265054 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010184221 | NHSA |
| 杭州泓友医药科技有限公司 | 国药准字H20263287 | 80mg (按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010184222 | NHSA |
| 广东万泰元科创药业有限公司 | 国药准字H20266011 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010185190 | NHSA |
| 北京诺华制药有限公司 | 国药准字H20090179 | 80mg | Category B (乙) | XC10AAF067A010010200100 | NHSA |
| 北京世桥生物制药有限公司 | 国药准字H20213801 | 80mg(按C24H26FNO4计) | Category B (乙) | XC10AAF067A010010200123 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20234643 | 80mg(按C24H26FNO4计) | Category B (乙) | XC10AAF067A010010200177 | NHSA |
| 浙江昂利康制药股份有限公司 | 国药准字H20264495 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010204606 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20264130 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010204647 | NHSA |
| 浙江普洛康裕制药有限公司 | 国药准字H20263882 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010204685 | NHSA |
| 浙江高跖医药科技股份有限公司 | 国药准字H20265054 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010284221 | NHSA |
| 杭州泓友医药科技有限公司 | 国药准字H20263287 | 80mg (按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010284222 | NHSA |
| 广东万泰元科创药业有限公司 | 国药准字H20266011 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010285190 | NHSA |
| 北京世桥生物制药有限公司 | 国药准字H20213801 | 80mg(按C24H26FNO4计) | Category B (乙) | XC10AAF067A010010300123 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20234643 | 80mg(按C24H26FNO4计) | Category B (乙) | XC10AAF067A010010300177 | NHSA |
| 浙江昂利康制药股份有限公司 | 国药准字H20264495 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010304606 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20264130 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010304647 | NHSA |
| 浙江普洛康裕制药有限公司 | 国药准字H20263882 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010304685 | NHSA |
| 浙江高跖医药科技股份有限公司 | 国药准字H20265054 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010384221 | NHSA |
| 广东万泰元科创药业有限公司 | 国药准字H20266011 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010385190 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20234643 | 80mg(按C24H26FNO4计) | Category B (乙) | XC10AAF067A010010400177 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20264130 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010404647 | NHSA |
| 浙江普洛康裕制药有限公司 | 国药准字H20263882 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010404685 | NHSA |
| 浙江高跖医药科技股份有限公司 | 国药准字H20265054 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010484221 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20234643 | 80mg(按C24H26FNO4计) | Category B (乙) | XC10AAF067A010010500177 | NHSA |
| 浙江高跖医药科技股份有限公司 | 国药准字H20265054 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010584221 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20234643 | 80mg(按C24H26FNO4计) | Category B (乙) | XC10AAF067A010010600177 | NHSA |
| 浙江高跖医药科技股份有限公司 | 国药准字H20265054 | 80mg(按C₂₄H₂₆FNO₄计) | Category B (乙) | XC10AAF067A010010684221 | NHSA |
| 北京诺华制药有限公司 | 国药准字H20090179 | 80mg | Category B (乙) | XC10AAF067A010020100100 | 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 6 distinct first applicants.
Generic 6
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京易亨制药有限公司 | CYHS2601303 | Generic | 2026/06/04 | Not stated by source | CDE |
| 国药集团致君（深圳）坪山制药有限公司 | CYHS2601902 | Generic | 2026/08/05 | Not stated by source | CDE |
| 浙江百代医药科技有限公司;浙江赛默制药有限公司 | CYHS2601861 | Generic | 2026/08/03 | Not stated by source | CDE |
| 上海海虹实业（集团）巢湖今辰药业有限公司 | CYHS2600535 | Generic | 2026/02/26 | Not stated by source | CDE |
| 广东安诺药业股份有限公司 | CYHS2600069 | Generic | 2026/01/08 | Not stated by source | CDE |
| 深圳信立泰药业股份有限公司 | CYHS2503534 | Generic | 2025/09/28 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 5 filings and 5 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京易亨制药有限公司 | CYHS2601303 | Generic | 2026/06/04 | Not stated by source | CDE |
| 国药集团致君（深圳）坪山制药有限公司 | CYHS2601902 | Generic | 2026/08/05 | Not stated by source | CDE |
| 浙江百代医药科技有限公司;浙江赛默制药有限公司 | CYHS2601861 | Generic | 2026/08/03 | Not stated by source | CDE |
| 上海海虹实业（集团）巢湖今辰药业有限公司 | CYHS2600535 | Generic | 2026/02/26 | Not stated by source | CDE |
| 广东安诺药业股份有限公司 | CYHS2600069 | Generic | 2026/01/08 | Not stated by source | CDE |
API registrations
Non-component matches: 9 companies with A status and 2 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 |
|---|---|---|---|---|---|---|
| 氟伐他汀钠 | 山东信立泰药业有限公司 | Y20250000881 | A | Exact ingredient | 2026/10/29 | CDE |
| 氟伐他汀钠 | 浙江奥翔药业股份有限公司 | Y20240001245 | A | Exact ingredient | 2026/06/01 | CDE |
| 氟伐他汀钠 | 浙江乐普药业股份有限公司 | Y20230001392 | A | Exact ingredient | 2026/05/18 | CDE |
| 氟伐他汀钠 | 浙江乐普药业股份有限公司 | Y20230001125 | I | Exact ingredient | 2023/12/26 | CDE |
| 氟伐他汀钠 | 湖南复瑞生物医药技术有限责任公司 | Y20230000029 | A | Exact ingredient | 2024/05/31 | CDE |
| 氟伐他汀钠 | Biocon Limited | Y20220000062 | A | Exact ingredient | 2025/06/07 | CDE |
| 氟伐他汀钠 | 深圳信立泰药业股份有限公司 | Y20190009733 | A | Exact ingredient | 2025/01/27 | CDE |
| 氟伐他汀钠 | Novartis Pharma Schweiz AG | Y20190009107 | A | Exact ingredient | 2024/10/17 | CDE |
| 氟伐他汀钠 | 浙江海正药业股份有限公司 | Y20190003577 | A | Exact ingredient | 2025/02/28 | CDE |
| 氟伐他汀钠 | Teva API India Private Limited | Y20180001125 | A | Exact ingredient | 2025/03/20 | CDE |
| 氟伐他汀钠 | Novartis Pharma Schweiz A | Y20170001938 | 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.
- No matching records were found in the currently loaded source data; coverage dates are listed below.
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 Fluvastatin Sodium Extended Release Tablets
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