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Dydrogesterone Tablets

As 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.

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Complete CDE snapshot
2026/11/13 06:42
Matching scope
Same generic name; dosage forms and combinations kept separate

US Orange Book listing

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.

Same dosage form

Brand nameApplicant (source text)Application numberDosage 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)

Other dosage forms of the same ingredient

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.

Ingredient cross-list details ↗

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.

Chemical-drug catalogue

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 holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Hefei Guo Gao Pharma Co., Ltd. romanizedJiangsu He Chen Pharma Co., Ltd. romanized国药准字H202651622026/07/1410mgGeneric approved under the new chemical-drug registration classificationCDE
Henan Tai Feng Bio Technology Co., Ltd. romanizedHenan Tai Feng Bio Technology Co., Ltd. romanized国药准字H202650262026/06/3010mgGeneric approved under the new chemical-drug registration classificationCDE
Cipla Ltd.M/s Acme Formulation Pvt. Ltd.国药准字HJ202600652026/06/3010mgGeneric approved under the new chemical-drug registration classificationCDE
Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanizedHunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized国药准字H202643262026/05/1210mgGeneric approved under the new chemical-drug registration classificationCDE
Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanizedZhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H202640672026/04/2110mgGeneric approved under the new chemical-drug registration classificationCDE
Jia Heng (Zhuhai Heng Qin) Pharmaceuticals Technology Co., Ltd. romanizedJiangsu He Chen Pharma Co., Ltd. romanized国药准字H202640682026/04/2110mgGeneric approved under the new chemical-drug registration classificationCDE
Guangzhou Lang Sheng Pharma Co., Ltd. romanizedGuangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H202638672026/04/0710mgGeneric approved under the new chemical-drug registration classificationCDE
Xinjiang Te Feng Pharma Co., Ltd. romanizedXinjiang Xin Zi Yuan Biopharmaceutical Co., Ltd. romanized国药准字H202632222026/01/2710mgGeneric approved under the new chemical-drug registration classificationCDE
Zhu Zhou Qian Jin Pharma Co., Ltd. romanizedZhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H202565082025/12/3010mgGeneric approved under the new chemical-drug registration classificationCDE
Gui Lin Lang Ke Pharmaceutical Co., Ltd. romanizedZhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H202565022025/12/3010mgGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Ai Sheng Pharma Co., Ltd. romanizedZhejiang Ai Sheng Pharma Co., Ltd. romanized国药准字H202556872025/10/1410mgGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanizedZhejiang Xian Ju Pharmaceutical Co., Ltd. romanized国药准字H202540522025/04/3010mgGeneric approved under the new chemical-drug registration classificationCDE
Sichuan Kelun Pharmaceutical Co., Ltd.Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H202448722024/09/1010mgGeneric approved under the new chemical-drug registration classificationCDE
Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanizedYang Zhou Ao Rui Te Pharma Co., Ltd. romanized国药准字H202431632024/02/0610mgGeneric approved under the new chemical-drug registration classificationCDE
Ao Rui Te Pharma Co., Ltd. romanizedYang Zhou Ao Rui Te Pharma Co., Ltd. romanized国药准字H202337692023/06/2110mgGeneric approved under the new chemical-drug registration classificationCDE
Abbott Healthcare Products B.V.Abbott Biologicals B.V.H201702212002/12/3110mgImported originator drugCDE
Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanizedZhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H202549422025/07/2210mgGeneric approved under the new chemical-drug registration classificationCDE

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: 16 distinct approval numbers and 16 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanized国药准字H2026406710mgCategory BXG03DBD084A001010100085NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H2024487210mgCategory BXG03DBD084A001010102180NHSA
Henan Tai Feng Bio Technology Co., Ltd. romanized国药准字H2026502610mgCategory BXG03DBD084A001010103013NHSA
Zhejiang Ai Sheng Pharma Co., Ltd. romanized国药准字H2025568710mgCategory BXG03DBD084A001010104604NHSA
Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized国药准字H2025405210mgCategory BXG03DBD084A001010104735NHSA
Zhu Zhou Qian Jin Pharma Co., Ltd. romanized国药准字H2025650810mgCategory BXG03DBD084A001010105046NHSA
Xinjiang Te Feng Pharma Co., Ltd. romanized国药准字H2026322210mgCategory BXG03DBD084A001010105999NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H2026386710mgCategory BXG03DBD084A001010107360NHSA
Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized国药准字H2026432610mgCategory BXG03DBD084A001010107599NHSA
Ao Rui Te Pharma Co., Ltd. romanized国药准字H2023376910mgCategory BXG03DBD084A001010108121NHSA
Abbott B.V.国药准字HJ2017022110mgCategory BXG03DBD084A001010178890NHSA
Hefei Guo Gao Pharma Co., Ltd. romanized国药准字H2026516210mgCategory BXG03DBD084A001010183883NHSA
Jia Heng (Zhuhai Heng Qin) Pharmaceuticals Technology Co., Ltd. romanized国药准字H2026406810mgCategory BXG03DBD084A001010184183NHSA
Jiangsu He Chen Pharma Co., Ltd. romanized国药准字H2024316310mgCategory BXG03DBD084A001010184206NHSA
Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized国药准字H2025494210mgCategory BXG03DBD084A001010184221NHSA
Gui Lin Lang Ke Pharmaceutical Co., Ltd. romanized国药准字H2025650210mgCategory BXG03DBD084A001010185157NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H2024487210mgCategory BXG03DBD084A001010202180NHSA
Henan Tai Feng Bio Technology Co., Ltd. romanized国药准字H2026502610mgCategory BXG03DBD084A001010203013NHSA
Zhejiang Ai Sheng Pharma Co., Ltd. romanized国药准字H2025568710mgCategory BXG03DBD084A001010204604NHSA
Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized国药准字H2026432610mgCategory BXG03DBD084A001010207599NHSA
Ao Rui Te Pharma Co., Ltd. romanized国药准字H2023376910mgCategory BXG03DBD084A001010208121NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H2024487210mgCategory BXG03DBD084A001010302180NHSA
Henan Tai Feng Bio Technology Co., Ltd. romanized国药准字H2026502610mgCategory BXG03DBD084A001010303013NHSA
Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized国药准字H2026432610mgCategory BXG03DBD084A001010307599NHSA
Ao Rui Te Pharma Co., Ltd. romanized国药准字H2023376910mgCategory BXG03DBD084A001010308121NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H2024487210mgCategory BXG03DBD084A001010402180NHSA
Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized国药准字H2026432610mgCategory BXG03DBD084A001010407599NHSA
Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized国药准字H2026432610mgCategory BXG03DBD084A001010507599NHSA

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: 8 filings and 7 distinct first applicants.

Generic 6 · Supplement 2

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Shanghai Yan An Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanizedCYHS2602273Generic2026/09/15Not stated by sourceCDE
Abbott B. V.; Abbott Biologicals B. V.JYHB2600476Supplement2026/08/17Not stated by sourceCDE
Abbott B. V.; Abbott Biologicals B. V.JYHB2600379Supplement2026/07/13Not stated by sourceCDE
Wuhan Jiu Long Ren Fu Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.CYHS2601052Generic2026/05/08Not stated by sourceCDE
Hubei Min Kang Pharma Group Co., Ltd. romanized; Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanizedCYHS2600126Generic2026/01/10Not stated by sourceCDE
Zhejiang Shen Zhou Pharma Co., Ltd. romanizedCYHS2504386Generic2025/12/25Not stated by sourceCDE
Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized; Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanizedCYHS2503570Generic2025/09/29Not stated by sourceCDE
Beijing Si Li An Pharma Co., Ltd. romanizedCYHS2502270Generic2025/06/25Not stated by sourceCDE
New generic filings in 2026

Loaded records: 4 filings and 4 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanizedCYHS2602566Generic2026/10/19Not stated by sourceCDE
Shanghai Yan An Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanizedCYHS2602273Generic2026/09/15Not stated by sourceCDE
Wuhan Jiu Long Ren Fu Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.CYHS2601052Generic2026/05/08Not stated by sourceCDE
Hubei Min Kang Pharma Group Co., Ltd. romanized; Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanizedCYHS2600126Generic2026/01/10Not stated by sourceCDE
API registrations

Non-component matches: 4 companies with A status and 6 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
地屈孕酮 · No verified English nameLanzhou Te Feng Pharmaceutical Co., Ltd. romanizedY20250000513IExact ingredient2026/08/27CDE
地屈孕酮 · No verified English nameSichuan Ren An Pharma Co., Ltd. romanizedY20250001439IExact ingredient2026/03/17CDE
地屈孕酮 · No verified English nameQin Huang Dao Zi Zhu Pharma Co., Ltd. romanizedY20260000036IExact ingredient2026/02/14CDE
地屈孕酮 · No verified English nameZhejiang Shen Zhou Pharma Co., Ltd. romanizedY20250000718IExact ingredient2025/12/08CDE
地屈孕酮 · No verified English nameHunan Ke Yi Xin Biopharmaceuticals Co., Ltd. romanizedY20240000900AExact ingredient2026/03/31CDE
地屈孕酮 · No verified English nameJiangsu Jia Er Ke Pharma Group Co., Ltd. romanizedY20240000058AExact ingredient2025/07/18CDE
地屈孕酮 · No verified English nameZhejiang Xian Ju Pharmaceutical Co., Ltd. romanizedY20230000883AExact ingredient2025/04/28CDE
地屈孕酮 · No verified English nameYang Zhou Ao Rui Te Pharma Co., Ltd. romanizedY20210001253AExact ingredient2023/06/29CDE
地屈孕酮 · No verified English nameXian Guo Kang Rui Jin Pharmaceutical Co., Ltd. romanizedY20210000734IExact ingredient2021/09/23CDE
地屈孕酮 · No verified English nameHubei Ge Dian Ren Fu Pharma Co., Ltd. romanizedY20260000929IExact ingredient2026/11/11CDE

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.

  1. 2026/11/13No longer listed under review

    Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized

    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 ↗
  2. 2026/10/26Marketing application approved

    Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized

    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 ↗
  3. 2026/10/19Accepted

    Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized

    CYHS2602566

    Fact date: 2026/10/19 · Site observation date: 2026/10/21

    View source ↗
  4. 2026/09/15Accepted

    Shanghai Yan An Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized

    CYHS2602273

    Fact date: 2026/09/15 · Site observation date: 2026/10/22

    View source ↗
  5. 2026/08/17Accepted

    Abbott B. V.; Abbott Biologicals B. V.

    JYHB2600476

    Fact date: 2026/08/17 · 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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