Monthly
US$200
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Fudosteine oral solution(福多司坦口服溶液)
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 5 applicationsAccepted: 2 applicationsNo longer listed under review: 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 holders0View records ↓
Under-review filings7View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers23View records ↓
API companies with A status8View 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: 23 distinct approval numbers and 16 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 江苏联环药业股份有限公司 | 国药准字H20253714 | 100ml:8g | Category B (乙) | XR05CBF100X001010101467 | NHSA |
| 太康海恩药业有限公司 | 国药准字H20263636 | 100ml:8g | Category B (乙) | XR05CBF100X001010103172 | NHSA |
| 西洲医药科技(浙江)有限公司 | 国药准字H20223804 | 50ml:4g | Category B (乙) | XR05CBF100X001010104610 | NHSA |
| 浙江国镜药业有限公司 | 国药准字H20234089 | 500ml:40g | Category B (乙) | XR05CBF100X001010104634 | NHSA |
| 昆明南疆制药有限公司 | 国药准字H20253800 | 5ml:0.4g | Category B (乙) | XR05CBF100X001010105597 | NHSA |
| 北京诚济制药股份有限公司 | 国药准字H20213574 | 100ml:8g | Category B (乙) | XR05CBF100X001010182209 | NHSA |
| 江苏正大丰海制药有限公司 | 国药准字H20234185 | 100ml:8g | Category B (乙) | XR05CBF100X001010182834 | NHSA |
| 仁合益康集团有限公司 | 国药准字H20244296 | 90ml:7.2g | Category B (乙) | XR05CBF100X001010183033 | NHSA |
| 成都欣捷高新技术开发股份有限公司 | 国药准字H20255304 | 5ml∶0.4g | Category B (乙) | XR05CBF100X001010183325 | NHSA |
| 广东仁想药业有限公司 | 国药准字H20264924 | 100ml:8g | Category B (乙) | XR05CBF100X001010183370 | NHSA |
| 苏州华健瑞达医药技术有限公司 | 国药准字H20233361 | 5ml:0.4g | Category B (乙) | XR05CBF100X001010183418 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20263080 | 5ml:0.4g | Category B (乙) | XR05CBF100X001010183595 | NHSA |
| 北京民康百草医药科技有限公司 | 国药准字H20244662 | 100ml:8g | Category B (乙) | XR05CBF100X001010183644 | NHSA |
| 江苏开元药业有限公司 | 国药准字H20255297 | 100ml:8g | Category B (乙) | XR05CBF100X001010183955 | NHSA |
| 四川益生智同医药生物科技发展有限公司 | 国药准字H20253709 | 100ml: 8g | Category B (乙) | XR05CBF100X001010184204 | NHSA |
| 西洲医药科技(浙江)有限公司 | 国药准字H20247145 | 100ml:8g | Category B (乙) | XR05CBF100X001010184209 | NHSA |
| 东阳祥昇医药科技有限公司 | 国药准字H20255515 | 50ml:4g | Category B (乙) | XR05CBF100X001010184294 | NHSA |
| 苏州华健瑞达医药技术有限公司 | 国药准字H20233361 | 5ml:0.4g | Category B (乙) | XR05CBF100X001010283418 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20263080 | 5ml:0.4g | Category B (乙) | XR05CBF100X001010283595 | NHSA |
| 东阳祥昇医药科技有限公司 | 国药准字H20255515 | 50ml:4g | Category B (乙) | XR05CBF100X001010284294 | NHSA |
| 苏州华健瑞达医药技术有限公司 | 国药准字H20233361 | 5ml:0.4g | Category B (乙) | XR05CBF100X001010383418 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20263080 | 5ml:0.4g | Category B (乙) | XR05CBF100X001010383595 | NHSA |
| 苏州华健瑞达医药技术有限公司 | 国药准字H20233361 | 5ml:0.4g | Category B (乙) | XR05CBF100X001010483418 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20263080 | 5ml:0.4g | Category B (乙) | XR05CBF100X001010483595 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20263080 | 5ml:0.4g | Category B (乙) | XR05CBF100X001010583595 | NHSA |
| 太康海恩药业有限公司 | 国药准字H20263635 | 50ml:4g | Category B (乙) | XR05CBF100X001020103172 | NHSA |
| 浙江国镜药业有限公司 | 国药准字H20234090 | 120ml:9.6g | Category B (乙) | XR05CBF100X001020104634 | NHSA |
| 北京诚济制药股份有限公司 | 国药准字H20269024 | 50ml:4g | Category B (乙) | XR05CBF100X001020182209 | NHSA |
| 成都欣捷高新技术开发股份有限公司 | 国药准字H20255305 | 100ml∶8g | Category B (乙) | XR05CBF100X001020183325 | NHSA |
| 苏州华健瑞达医药技术有限公司 | 国药准字H20247310 | 120ml:9.6g | Category B (乙) | XR05CBF100X001020183418 | NHSA |
| 东阳祥昇医药科技有限公司 | 国药准字H20255516 | 100ml:8g | Category B (乙) | XR05CBF100X001020184294 | NHSA |
| 东阳祥昇医药科技有限公司 | 国药准字H20255516 | 100ml:8g | Category B (乙) | XR05CBF100X001020284294 | 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: 7 filings and 7 distinct first applicants.
Generic 4 · Supplement 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏润恒制药有限公司 | CYHS2500925 | Generic | 2025/03/05 | Not stated by source | CDE |
| 江苏晨牌邦德药业有限公司 | CYHS2600892 | Generic | 2026/04/18 | Not stated by source | CDE |
| 仁合益康集团有限公司;河北仁合益康药业有限公司 | CYHB2601914 | Supplement | 2026/10/20 | Not stated by source | CDE |
| 成都纵联医疗健康科技有限公司;四川先通药业有限责任公司 | CYHS2601588 | Generic | 2026/07/06 | Not stated by source | CDE |
| 浙江国镜药业有限公司 | CYHB2601131 | Supplement | 2026/06/16 | Not stated by source | CDE |
| 海南全星制药有限公司 | CYHS2502419 | Generic | 2025/07/08 | Not stated by source | CDE |
| 沂南力诺制药有限责任公司;天大药业（珠海）有限公司 | CYHB2601965 | Supplement | 2026/10/27 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 8 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 |
|---|---|---|---|---|---|---|
| 福多司坦 | 武汉远大弘元股份有限公司 | Y20220000395 | A | Exact ingredient | 2024/11/30 | CDE |
| 福多司坦 | 四川新开元制药有限公司 | Y20190009832 | A | Exact ingredient | — | CDE |
| 福多司坦 | 天方药业有限公司 | Y20190007408 | A | Exact ingredient | 2026/08/18 | CDE |
| 福多司坦 | 浙江国邦药业有限公司 | Y20190007283 | A | Exact ingredient | 2024/02/20 | CDE |
| 福多司坦 | 宜昌东阳光长江药业股份有限公司 | Y20190007268 | A | Exact ingredient | 2026/03/11 | CDE |
| 福多司坦 | 迪嘉药业集团股份有限公司 | Y20190006099 | A | Exact ingredient | 2025/11/27 | CDE |
| 福多司坦 | 连云港润众制药有限公司 | Y20190003327 | A | Exact ingredient | 2024/03/27 | CDE |
| 福多司坦 | 江苏正大丰海制药有限公司 | Y20190000727 | A | Exact ingredient | 2025/01/24 | CDE |
| 福多司坦 | 四川新开元制药有限公司 | Y20170002162 | A | Exact ingredient | 2026/06/16 | 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.
-
2026/11/03Marketing application approved
海南斯达制药有限公司
CYHS2403456 · 国药准字H20266484
Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06
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 9 ↗ -
2026/11/03Marketing application approved
海南斯达制药有限公司
CYHS2403455 · 国药准字H20266483
Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06
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 8 ↗ -
2026/11/03Marketing application approved
海南斯达制药有限公司
CYHS2403454 · 国药准字H20266482
Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06
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 7 ↗ -
2026/10/28No longer listed under review
湖南一格制药有限公司
CYHS2501555
Fact date: 2026/10/28 · Site observation date: 2026/10/28
Accepted: 2025/04/25
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/28No longer listed under review
湖南一格制药有限公司
CYHS2501554
Fact date: 2026/10/28 · Site observation date: 2026/10/28
Accepted: 2025/04/25
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/27Accepted
沂南力诺制药有限责任公司;天大药业（珠海）有限公司
CYHB2601965
Fact date: 2026/10/27 · Site observation date: 2026/10/28
View source ↗ -
2026/10/26Marketing application approved
温岭市创新生物医药科技股份有限公司
CYHS2500024 · 国药准字H20266413
Fact date: 2026/10/26 · Publication date: 2026/10/27 · 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 27 ↗ -
2026/10/26Marketing application approved
温岭市创新生物医药科技股份有限公司
CYHS2500023 · 国药准字H20266412
Fact date: 2026/10/26 · Publication date: 2026/10/27 · 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 26 ↗ -
2026/10/20Accepted
仁合益康集团有限公司;河北仁合益康药业有限公司
CYHB2601914
Fact date: 2026/10/20 · 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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