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Sign in to subscribeFudosteine oral solution
As of 13 November 2026, for Fudosteine oral solution, 7 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 0 holders.
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.
Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.
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 |
|---|---|---|---|---|---|
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | 国药准字H20253714 | 100ml:8g | Category B | XR05CBF100X001010101467 | NHSA |
| Tai Kang Hai En Pharma Co., Ltd. romanized | 国药准字H20263636 | 100ml:8g | Category B | XR05CBF100X001010103172 | NHSA |
| Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized | 国药准字H20223804 | 50ml:4g | Category B | XR05CBF100X001010104610 | NHSA |
| Zhejiang Guo Jing Pharma Co., Ltd. romanized | 国药准字H20234089 | 500ml:40g | Category B | XR05CBF100X001010104634 | NHSA |
| Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized | 国药准字H20253800 | 5ml:0.4g | Category B | XR05CBF100X001010105597 | NHSA |
| Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized | 国药准字H20213574 | 100ml:8g | Category B | XR05CBF100X001010182209 | NHSA |
| Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized | 国药准字H20234185 | 100ml:8g | Category B | XR05CBF100X001010182834 | NHSA |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H20244296 | 90ml:7.2g | Category B | XR05CBF100X001010183033 | NHSA |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H20255304 | 5ml∶0.4g | Category B | XR05CBF100X001010183325 | NHSA |
| Guangdong Ren Xiang Pharma Co., Ltd. romanized | 国药准字H20264924 | 100ml:8g | Category B | XR05CBF100X001010183370 | NHSA |
| Suzhou Hua Jian Rui Da Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20233361 | 5ml:0.4g | Category B | XR05CBF100X001010183418 | NHSA |
| Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20263080 | 5ml:0.4g | Category B | XR05CBF100X001010183595 | NHSA |
| Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20244662 | 100ml:8g | Category B | XR05CBF100X001010183644 | NHSA |
| Jiangsu Kai Yuan Pharma Co., Ltd. romanized | 国药准字H20255297 | 100ml:8g | Category B | XR05CBF100X001010183955 | NHSA |
| Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized | 国药准字H20253709 | 100ml: 8g | Category B | XR05CBF100X001010184204 | NHSA |
| Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized | 国药准字H20247145 | 100ml:8g | Category B | XR05CBF100X001010184209 | NHSA |
| Name not romanized | 国药准字H20255515 | 50ml:4g | Category B | XR05CBF100X001010184294 | NHSA |
| Suzhou Hua Jian Rui Da Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20233361 | 5ml:0.4g | Category B | XR05CBF100X001010283418 | NHSA |
| Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20263080 | 5ml:0.4g | Category B | XR05CBF100X001010283595 | NHSA |
| Name not romanized | 国药准字H20255515 | 50ml:4g | Category B | XR05CBF100X001010284294 | NHSA |
| Suzhou Hua Jian Rui Da Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20233361 | 5ml:0.4g | Category B | XR05CBF100X001010383418 | NHSA |
| Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20263080 | 5ml:0.4g | Category B | XR05CBF100X001010383595 | NHSA |
| Suzhou Hua Jian Rui Da Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20233361 | 5ml:0.4g | Category B | XR05CBF100X001010483418 | NHSA |
| Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20263080 | 5ml:0.4g | Category B | XR05CBF100X001010483595 | NHSA |
| Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20263080 | 5ml:0.4g | Category B | XR05CBF100X001010583595 | NHSA |
| Tai Kang Hai En Pharma Co., Ltd. romanized | 国药准字H20263635 | 50ml:4g | Category B | XR05CBF100X001020103172 | NHSA |
| Zhejiang Guo Jing Pharma Co., Ltd. romanized | 国药准字H20234090 | 120ml:9.6g | Category B | XR05CBF100X001020104634 | NHSA |
| Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized | 国药准字H20269024 | 50ml:4g | Category B | XR05CBF100X001020182209 | NHSA |
| Chengdu Giantech Hi-technology Development Co., Ltd. | 国药准字H20255305 | 100ml∶8g | Category B | XR05CBF100X001020183325 | NHSA |
| Suzhou Hua Jian Rui Da Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20247310 | 120ml:9.6g | Category B | XR05CBF100X001020183418 | NHSA |
| Name not romanized | 国药准字H20255516 | 100ml:8g | Category B | XR05CBF100X001020184294 | NHSA |
| Name not romanized | 国药准字H20255516 | 100ml:8g | Category B | 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 |
|---|---|---|---|---|---|
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | CYHS2500925 | Generic | 2025/03/05 | Not stated by source | CDE |
| Jiangsu Chen Pai Bang De Pharma Co., Ltd. romanized | CYHS2600892 | Generic | 2026/04/18 | Not stated by source | CDE |
| Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized | CYHB2601914 | Supplement | 2026/10/20 | Not stated by source | CDE |
| Chengdu Zong Lian Medical Health Technology Co., Ltd. romanized; Sichuan Xian Tong Pharma Co., Ltd. romanized | CYHS2601588 | Generic | 2026/07/06 | Not stated by source | CDE |
| Zhejiang Guo Jing Pharma Co., Ltd. romanized | CYHB2601131 | Supplement | 2026/06/16 | Not stated by source | CDE |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | CYHS2502419 | Generic | 2025/07/08 | Not stated by source | CDE |
| Yi Nan Li Nuo Pharmaceutical Co., Ltd. romanized; Tian Da Pharma (Zhuhai) Co., Ltd. romanized | CYHB2601965 | Supplement | 2026/10/27 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jiangsu Chen Pai Bang De Pharma Co., Ltd. romanized | CYHS2600892 | Generic | 2026/04/18 | Not stated by source | CDE |
| Chengdu Zong Lian Medical Health Technology Co., Ltd. romanized; Sichuan Xian Tong Pharma Co., Ltd. romanized | CYHS2601588 | Generic | 2026/07/06 | Not stated by source | CDE |
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 · No verified English name | Wuhan Yuan Da Hong Yuan Co., Ltd. romanized | Y20220000395 | A | Exact ingredient | 2024/11/30 | CDE |
| 福多司坦 · No verified English name | Sichuan Xin Kai Yuan Pharmaceutical Co., Ltd. romanized | Y20190009832 | A | Exact ingredient | — | CDE |
| 福多司坦 · No verified English name | Topfond Pharmaceutical Co., Ltd. | Y20190007408 | A | Exact ingredient | 2026/08/18 | CDE |
| 福多司坦 · No verified English name | Zhejiang Guo Bang Pharma Co., Ltd. romanized | Y20190007283 | A | Exact ingredient | 2024/02/20 | CDE |
| 福多司坦 · No verified English name | Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | Y20190007268 | A | Exact ingredient | 2026/03/11 | CDE |
| 福多司坦 · No verified English name | Di Jia Pharma Group Co., Ltd. romanized | Y20190006099 | A | Exact ingredient | 2025/11/27 | CDE |
| 福多司坦 · No verified English name | Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanized | Y20190003327 | A | Exact ingredient | 2024/03/27 | CDE |
| 福多司坦 · No verified English name | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized | Y20190000727 | A | Exact ingredient | 2025/01/24 | CDE |
| 福多司坦 · No verified English name | Sichuan Xin Kai Yuan Pharmaceutical Co., Ltd. romanized | 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: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.
-
2026/11/03Marketing application approved
Hainan Si Da Pharmaceutical Co., Ltd. romanized
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
Hainan Si Da Pharmaceutical Co., Ltd. romanized
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
Hainan Si Da Pharmaceutical Co., Ltd. romanized
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
Hunan Yi Ge Pharmaceutical Co., Ltd. romanized
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
Hunan Yi Ge Pharmaceutical Co., Ltd. romanized
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
Yi Nan Li Nuo Pharmaceutical Co., Ltd. romanized; Tian Da Pharma (Zhuhai) Co., Ltd. romanized
CYHB2601965
Fact date: 2026/10/27 · Site observation date: 2026/10/28
View source ↗ -
2026/10/26Marketing application approved
Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized
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
Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized
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
Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
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: 2026/11/13 06:42
- Chemical-drug catalogue
- Last successful update: 2026/11/13 06:39
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: 2026/11/13 06:41
- 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: 2026/11/12 18:32 · Current coverage may be incomplete
First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/13 08:09 · 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: 7/30; discovered pending details: 13. 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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