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Sign in to subscribeAs of 13 November 2026, for Dydrogesterone Tablets, 8 applications are listed as under review at China's CDE; 4 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 17 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 3 applicationsNo longer listed under review: 1 application
Current coverage may be incomplete
The brand names come from the US FDA Orange Book and describe US listing records for this active ingredient. They do not indicate that products under these brand names are approved or sold in China, or that Chinese applicants are affiliated with US holders.
Orange Book source export date: 2026/11/06. Version: 2026-11-06.
Showing 1 of 1 distinct brand names.
A brand with different source forms or statuses can appear on multiple rows and in both groups. Distinct brand names are counted once globally, with a limit of five.
Verified official English dosage form: Tablets. Listings are grouped by the source dosage form and route; records without a clear correspondence are listed in the other group. Grouping does not establish product equivalence.
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| GYNOREST | SOLVAY PHARMACEUTICALS | NDA 017388 · Product no. 001, 002 | TABLET | ORAL | DISCONTINUED | Approved prior to 1982 (exact date not listed) |
No listings in this group among the displayed brand names.
Same-form/route listings come first, followed by other forms/routes. Within each group, source prescription/OTC listings precede discontinued listings; unknown statuses are last. Each status bucket is ordered by earliest approval date, ascending: pre-1982 records first, missing dates last; ties by brand name, application number and product number. The first five distinct brands in this order are selected globally. All retained source facts for those brands are shown in their own groups; a brand spanning both groups counts once.
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.
Loaded records: 17 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 16 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 |
|---|---|---|---|---|---|---|
| Hefei Guo Gao Pharma Co., Ltd. romanized | Jiangsu He Chen Pharma Co., Ltd. romanized | 国药准字H20265162 | 2026/07/14 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Henan Tai Feng Bio Technology Co., Ltd. romanized | Henan Tai Feng Bio Technology Co., Ltd. romanized | 国药准字H20265026 | 2026/06/30 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Cipla Ltd. | M/s Acme Formulation Pvt. Ltd. | 国药准字HJ20260065 | 2026/06/30 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized | Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20264326 | 2026/05/12 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20264067 | 2026/04/21 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jia Heng (Zhuhai Heng Qin) Pharmaceuticals Technology Co., Ltd. romanized | Jiangsu He Chen Pharma Co., Ltd. romanized | 国药准字H20264068 | 2026/04/21 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20263867 | 2026/04/07 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Xinjiang Te Feng Pharma Co., Ltd. romanized | Xinjiang Xin Zi Yuan Biopharmaceutical Co., Ltd. romanized | 国药准字H20263222 | 2026/01/27 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhu Zhou Qian Jin Pharma Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20256508 | 2025/12/30 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Gui Lin Lang Ke Pharmaceutical Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20256502 | 2025/12/30 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Ai Sheng Pharma Co., Ltd. romanized | Zhejiang Ai Sheng Pharma Co., Ltd. romanized | 国药准字H20255687 | 2025/10/14 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H20254052 | 2025/04/30 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Kelun Pharmaceutical Co., Ltd. | Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20244872 | 2024/09/10 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized | Yang Zhou Ao Rui Te Pharma Co., Ltd. romanized | 国药准字H20243163 | 2024/02/06 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Ao Rui Te Pharma Co., Ltd. romanized | Yang Zhou Ao Rui Te Pharma Co., Ltd. romanized | 国药准字H20233769 | 2023/06/21 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Abbott Healthcare Products B.V. | Abbott Biologicals B.V. | H20170221 | 2002/12/31 | 10mg | Imported originator drug | CDE |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20254942 | 2025/07/22 | 10mg | Generic approved under the new chemical-drug registration classification | 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.
Loaded records: 16 distinct approval numbers and 16 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanized | 国药准字H20264067 | 10mg | Category B | XG03DBD084A001010100085 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20244872 | 10mg | Category B | XG03DBD084A001010102180 | NHSA |
| Henan Tai Feng Bio Technology Co., Ltd. romanized | 国药准字H20265026 | 10mg | Category B | XG03DBD084A001010103013 | NHSA |
| Zhejiang Ai Sheng Pharma Co., Ltd. romanized | 国药准字H20255687 | 10mg | Category B | XG03DBD084A001010104604 | NHSA |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H20254052 | 10mg | Category B | XG03DBD084A001010104735 | NHSA |
| Zhu Zhou Qian Jin Pharma Co., Ltd. romanized | 国药准字H20256508 | 10mg | Category B | XG03DBD084A001010105046 | NHSA |
| Xinjiang Te Feng Pharma Co., Ltd. romanized | 国药准字H20263222 | 10mg | Category B | XG03DBD084A001010105999 | NHSA |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20263867 | 10mg | Category B | XG03DBD084A001010107360 | NHSA |
| Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20264326 | 10mg | Category B | XG03DBD084A001010107599 | NHSA |
| Ao Rui Te Pharma Co., Ltd. romanized | 国药准字H20233769 | 10mg | Category B | XG03DBD084A001010108121 | NHSA |
| Abbott B.V. | 国药准字HJ20170221 | 10mg | Category B | XG03DBD084A001010178890 | NHSA |
| Hefei Guo Gao Pharma Co., Ltd. romanized | 国药准字H20265162 | 10mg | Category B | XG03DBD084A001010183883 | NHSA |
| Jia Heng (Zhuhai Heng Qin) Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264068 | 10mg | Category B | XG03DBD084A001010184183 | NHSA |
| Jiangsu He Chen Pharma Co., Ltd. romanized | 国药准字H20243163 | 10mg | Category B | XG03DBD084A001010184206 | NHSA |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254942 | 10mg | Category B | XG03DBD084A001010184221 | NHSA |
| Gui Lin Lang Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20256502 | 10mg | Category B | XG03DBD084A001010185157 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20244872 | 10mg | Category B | XG03DBD084A001010202180 | NHSA |
| Henan Tai Feng Bio Technology Co., Ltd. romanized | 国药准字H20265026 | 10mg | Category B | XG03DBD084A001010203013 | NHSA |
| Zhejiang Ai Sheng Pharma Co., Ltd. romanized | 国药准字H20255687 | 10mg | Category B | XG03DBD084A001010204604 | NHSA |
| Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20264326 | 10mg | Category B | XG03DBD084A001010207599 | NHSA |
| Ao Rui Te Pharma Co., Ltd. romanized | 国药准字H20233769 | 10mg | Category B | XG03DBD084A001010208121 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20244872 | 10mg | Category B | XG03DBD084A001010302180 | NHSA |
| Henan Tai Feng Bio Technology Co., Ltd. romanized | 国药准字H20265026 | 10mg | Category B | XG03DBD084A001010303013 | NHSA |
| Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20264326 | 10mg | Category B | XG03DBD084A001010307599 | NHSA |
| Ao Rui Te Pharma Co., Ltd. romanized | 国药准字H20233769 | 10mg | Category B | XG03DBD084A001010308121 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20244872 | 10mg | Category B | XG03DBD084A001010402180 | NHSA |
| Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20264326 | 10mg | Category B | XG03DBD084A001010407599 | NHSA |
| Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20264326 | 10mg | Category B | XG03DBD084A001010507599 | 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.
Loaded records: 8 filings and 7 distinct first applicants.
Generic 6 · Supplement 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Shanghai Yan An Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2602273 | Generic | 2026/09/15 | Not stated by source | CDE |
| Abbott B. V.; Abbott Biologicals B. V. | JYHB2600476 | Supplement | 2026/08/17 | Not stated by source | CDE |
| Abbott B. V.; Abbott Biologicals B. V. | JYHB2600379 | Supplement | 2026/07/13 | Not stated by source | CDE |
| Wuhan Jiu Long Ren Fu Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. | CYHS2601052 | Generic | 2026/05/08 | Not stated by source | CDE |
| Hubei Min Kang Pharma Group Co., Ltd. romanized; Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized | CYHS2600126 | Generic | 2026/01/10 | Not stated by source | CDE |
| Zhejiang Shen Zhou Pharma Co., Ltd. romanized | CYHS2504386 | Generic | 2025/12/25 | Not stated by source | CDE |
| Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized; Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | CYHS2503570 | Generic | 2025/09/29 | Not stated by source | CDE |
| Beijing Si Li An Pharma Co., Ltd. romanized | CYHS2502270 | Generic | 2025/06/25 | Not stated by source | CDE |
Loaded records: 4 filings and 4 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized | CYHS2602566 | Generic | 2026/10/19 | Not stated by source | CDE |
| Shanghai Yan An Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2602273 | Generic | 2026/09/15 | Not stated by source | CDE |
| Wuhan Jiu Long Ren Fu Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. | CYHS2601052 | Generic | 2026/05/08 | Not stated by source | CDE |
| Hubei Min Kang Pharma Group Co., Ltd. romanized; Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized | CYHS2600126 | Generic | 2026/01/10 | Not stated by source | CDE |
Non-component matches: 4 companies with A status and 6 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 |
|---|---|---|---|---|---|---|
| 地屈孕酮 · No verified English name | Lanzhou Te Feng Pharmaceutical Co., Ltd. romanized | Y20250000513 | I | Exact ingredient | 2026/08/27 | CDE |
| 地屈孕酮 · No verified English name | Sichuan Ren An Pharma Co., Ltd. romanized | Y20250001439 | I | Exact ingredient | 2026/03/17 | CDE |
| 地屈孕酮 · No verified English name | Qin Huang Dao Zi Zhu Pharma Co., Ltd. romanized | Y20260000036 | I | Exact ingredient | 2026/02/14 | CDE |
| 地屈孕酮 · No verified English name | Zhejiang Shen Zhou Pharma Co., Ltd. romanized | Y20250000718 | I | Exact ingredient | 2025/12/08 | CDE |
| 地屈孕酮 · No verified English name | Hunan Ke Yi Xin Biopharmaceuticals Co., Ltd. romanized | Y20240000900 | A | Exact ingredient | 2026/03/31 | CDE |
| 地屈孕酮 · No verified English name | Jiangsu Jia Er Ke Pharma Group Co., Ltd. romanized | Y20240000058 | A | Exact ingredient | 2025/07/18 | CDE |
| 地屈孕酮 · No verified English name | Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | Y20230000883 | A | Exact ingredient | 2025/04/28 | CDE |
| 地屈孕酮 · No verified English name | Yang Zhou Ao Rui Te Pharma Co., Ltd. romanized | Y20210001253 | A | Exact ingredient | 2023/06/29 | CDE |
| 地屈孕酮 · No verified English name | Xian Guo Kang Rui Jin Pharmaceutical Co., Ltd. romanized | Y20210000734 | I | Exact ingredient | 2021/09/23 | CDE |
| 地屈孕酮 · No verified English name | Hubei Ge Dian Ren Fu Pharma Co., Ltd. romanized | Y20260000929 | I | Exact ingredient | 2026/11/11 | 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.
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.
CYHS2602566
Fact date: 2026/11/13 · Site observation date: 2026/11/13
Accepted: 2026/10/19
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗JYHS2500004 · 国药准字HJ20260092
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 70 ↗CYHS2602566
Fact date: 2026/10/19 · Site observation date: 2026/10/21
View source ↗CYHS2602273
Fact date: 2026/09/15 · Site observation date: 2026/10/22
View source ↗JYHB2600476
Fact date: 2026/08/17 · Site observation date: 2026/10/22
View source ↗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.
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.
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.
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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