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Levonorgestrel Tablets

As of 13 November 2026, for Levonorgestrel Tablets, 5 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 8 holders.

Companies, stages and changes, with each record available on this page.

Listed in the US FDA Orange Book as PLAN B ONE-STEP (NDA 021998, FOUNDATION CONSUMER HEALTHCARE LLC).

Last 90 days: Accepted: 1 applicationSupplement delivery: 1 application

Current coverage may be incomplete

Follow for free
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 5 of 9 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
PLAN B ONE-STEP FOUNDATION CONSUMER HEALTHCARE LLC NDA 021998 · Product no. 001 TABLET ORAL HUMAN OTC DRUG 2009/07/10
PLAN B FOUNDATION CONSUMER HEALTHCARE LLC NDA 021045 · Product no. 001 TABLET ORAL DISCONTINUED 1999/07/28
PLAN B FOUNDATION CONSUMER HEALTHCARE LLC NDA 021045 · Product no. 002 TABLET ORAL DISCONTINUED 2006/08/24

Other dosage forms of the same ingredient

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
MIRENA BAYER HEALTHCARE PHARMACEUTICALS INC NDA 021225 · Product no. 001 SYSTEM INTRAUTERINE HUMAN PRESCRIPTION DRUG 2000/12/06
SKYLA BAYER HEALTHCARE PHARMACEUTICALS INC NDA 203159 · Product no. 001 SYSTEM INTRAUTERINE HUMAN PRESCRIPTION DRUG 2013/01/09
LILETTA MEDICINES360 NDA 206229 · Product no. 001 SYSTEM INTRAUTERINE HUMAN PRESCRIPTION DRUG 2015/02/26

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: 8 holders; 3 in the quality-and-efficacy consistency-evaluation category, and 4 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Guangzhou Lang Sheng Pharma Co., Ltd. romanizedGuangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H202543982025/05/271.5mgGeneric approved under the new chemical-drug registration classificationCDE
EXELTIS HEALTHCARE S.L.LABORATORIOS LEON FARMA, S.A.国药准字HJ202401612024/12/061.5mgGeneric approved under the new chemical-drug registration classificationCDE
Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanizedDong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized国药准字H199831772022/09/130.75mgDrug that passed quality-and-efficacy consistency evaluationCDE
Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanizedDong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized国药准字H200585822022/09/131.5mgDrug that passed quality-and-efficacy consistency evaluationCDE
Hua Run Zi Zhu Pharma Co., Ltd. romanizedHua Run Zi Zhu Pharma Co., Ltd. romanized国药准字H109831292022/08/030.75mgDrug that passed quality-and-efficacy consistency evaluationCDE
Hua Run Zi Zhu Pharma Co., Ltd. romanizedHua Run Zi Zhu Pharma Co., Ltd. romanized国药准字H110213722022/08/031.5mgDrug that passed quality-and-efficacy consistency evaluationCDE
Nan Tong Lian Ya Pharma Co., Ltd. romanizedNan Tong Lian Ya Pharma Co., Ltd. romanized国药准字H202230382022/01/301.5mgGeneric approved under the new chemical-drug registration classificationCDE
Shanghai Xin Yi Tian Ping Pharma Co., Ltd. romanizedShanghai Xin Yi Tian Ping Pharma Co., Ltd. romanized国药准字H201631762020/09/081.5mgDrug that passed quality-and-efficacy consistency evaluationCDE
Shanghai Xin Yi Tian Ping Pharma Co., Ltd. romanizedShanghai Xin Yi Tian Ping Pharma Co., Ltd. romanized国药准字H200932592020/09/080.75mgDrug that passed quality-and-efficacy consistency evaluationCDE
Gedeon Richter Plc.Gedeon Richter Plc.H201407282009/12/241.5 mgImported originator drugCDE
Gedeon Richter Plc.Gedeon Richter Plc.H201400532000/04/260.75 mgImported originator drugCDE
Wuhan Jiu Long Ren Fu Pharma Co., Ltd. romanizedWuhan Jiu Long Ren Fu Pharma Co., Ltd. romanized国药准字H202554222025/09/091.5mgGeneric 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: 19 distinct approval numbers and 14 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Beijing Li Ling Heng Tai Pharma Co., Ltd. romanized国药准字H199830720.75mgNot stated by sourceXG03ADZ061A001010100088NHSA
Beijing Fu Ya Dong Investment Management Co., Ltd. romanized国药准字H201840760.75mgNot stated by sourceXG03ADZ061A001010100200NHSA
Hua Run Zi Zhu Pharma Co., Ltd. romanized国药准字H109831290.75mgNot stated by sourceXG03ADZ061A001010100225NHSA
Shanghai Xin Yi Tian Ping Pharma Co., Ltd. romanized国药准字H201631761.5mgNot stated by sourceXG03ADZ061A001010100800NHSA
Shanghai Xin Yi Tian Ping Pharma Co., Ltd. romanized国药准字H200932590.75mgNot stated by sourceXG03ADZ061A001010100803NHSA
Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized国药准字H199831770.75mgNot stated by sourceXG03ADZ061A001010101161NHSA
Hua Zhong Pharma Co., Ltd. romanized国药准字H200232960.75mgNot stated by sourceXG03ADZ061A001010101884NHSA
Sichuan Chuan Da Hua Xi Pharma Co., Ltd. romanized国药准字H201132120.75mgNot stated by sourceXG03ADZ061A001010102129NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H202543981.5mgNot stated by sourceXG03ADZ061A001010107360NHSA
Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized国药准字H201330811.5mgNot stated by sourceXG03ADZ061A001010107599NHSA
Gedeon Richter Plc.国药准字HJ201407281.5mgNot stated by sourceXG03ADZ061A001010179164NHSA
Shandong Xin Hui Pharma Co., Ltd. romanized国药准字H201840360.75mgNot stated by sourceXG03ADZ061A001010180465NHSA
Wuhan Jiu Long Ren Fu Pharma Co., Ltd. romanized国药准字H202554221.5mgNot stated by sourceXG03ADZ061A001010183319NHSA
Nan Tong Lian Ya Pharma Co., Ltd. romanized国药准字H202230381.5 mgNot stated by sourceXG03ADZ061A001010183802NHSA
Maxmind Pharmaceutical GmbH国药准字HJ202401611.5mgNot stated by sourceXG03ADZ061A001010185381NHSA
Beijing Li Ling Heng Tai Pharma Co., Ltd. romanized国药准字H199830720.75mgNot stated by sourceXG03ADZ061A001010200088NHSA
Shanghai Xin Yi Tian Ping Pharma Co., Ltd. romanized国药准字H200932590.75mgNot stated by sourceXG03ADZ061A001010200803NHSA
Hua Zhong Pharma Co., Ltd. romanized国药准字H200232960.75mgNot stated by sourceXG03ADZ061A001010201884NHSA
Sichuan Chuan Da Hua Xi Pharma Co., Ltd. romanized国药准字H201132120.75mgNot stated by sourceXG03ADZ061A001010202129NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H202543981.5mgNot stated by sourceXG03ADZ061A001010207360NHSA
Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized国药准字H201330811.5mgNot stated by sourceXG03ADZ061A001010207599NHSA
Shandong Xin Hui Pharma Co., Ltd. romanized国药准字H201840360.75mgNot stated by sourceXG03ADZ061A001010280465NHSA
Beijing Li Ling Heng Tai Pharma Co., Ltd. romanized国药准字H201030261.5mgNot stated by sourceXG03ADZ061A001020100088NHSA
Hua Run Zi Zhu Pharma Co., Ltd. romanized国药准字H110213721.5mgNot stated by sourceXG03ADZ061A001020100225NHSA
Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized国药准字H200585821.5mgNot stated by sourceXG03ADZ061A001020101161NHSA
Shandong Xin Hui Pharma Co., Ltd. romanized国药准字H201840351.5mgNot stated by sourceXG03ADZ061A001020180465NHSA
Beijing Li Ling Heng Tai Pharma Co., Ltd. romanized国药准字H201030261.5mgNot stated by sourceXG03ADZ061A001020200088NHSA
Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized国药准字H200585821.5mgNot stated by sourceXG03ADZ061A001020201161NHSA
Shandong Xin Hui Pharma Co., Ltd. romanized国药准字H201840351.5mgNot stated by sourceXG03ADZ061A001020280465NHSA
Hua Run Zi Zhu Pharma Co., Ltd. romanized国药准字H110213721.5mgNot stated by sourceXG03ADZ061A001020300225NHSA

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: 5 filings and 4 distinct first applicants.

Supplement 1 · Generic 4

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Gedeon Richter Plc.JYHB2600275Supplement2026/05/14Not stated by sourceCDE
Zhu Zhou Qian Jin Pharma Co., Ltd. romanized; Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanizedCYHS2600047Generic2026/01/06Not stated by sourceCDE
Zhejiang Ai Sheng Pharma Co., Ltd. romanizedCYHS2600035Generic2026/01/06Not stated by sourceCDE
Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized; Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanizedCYHS2504100Generic2025/11/28Not stated by sourceCDE
Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized; Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanizedCYHS2504099Generic2025/11/28Not stated by sourceCDE
New generic filings in 2026

Loaded records: 2 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Zhu Zhou Qian Jin Pharma Co., Ltd. romanized; Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanizedCYHS2600047Generic2026/01/06Not stated by sourceCDE
Zhejiang Ai Sheng Pharma Co., Ltd. romanizedCYHS2600035Generic2026/01/06Not stated by sourceCDE
API registrations

Non-component matches: 7 companies with A status and 2 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
左炔诺孕酮 · No verified English nameJiangsu Lianhuan Pharmaceutical Co.,Ltd.Y20190009601AExact ingredient2025/07/18CDE
左炔诺孕酮 · No verified English nameHunan Ke Yi Xin Biopharmaceuticals Co., Ltd. romanizedY20220000428AExact ingredient2026/01/17CDE
左炔诺孕酮 · No verified English nameINDUSTRIALE CHIMICA SRLY20190000943AExact ingredient2025/01/28CDE
左炔诺孕酮 · No verified English nameBeijing Shi Ke Yi Feng Bio Technology Development Co., Ltd. romanizedY20190009473AExact ingredient—CDE
左炔诺孕酮 · No verified English nameHubei Ge Dian Ren Fu Pharma Co., Ltd. romanizedY20190007482AExact ingredient2026/07/08CDE
左炔诺孕酮 · No verified English nameQin Huang Dao Zi Zhu Pharma Co., Ltd. romanizedY20190003154AExact ingredient2026/09/29CDE
左炔诺孕酮 · No verified English nameHua Zhong Pharma Co., Ltd. romanizedY20190003122AExact ingredient2025/06/11CDE
左炔诺孕酮 · No verified English nameYang Zhou Pharmaceutical Co., Ltd. romanizedY20190000403IExact ingredient2019/05/28CDE
左炔诺孕酮 · No verified English nameBeijing Shi Ke Yi Feng Bio Technology Development Co., Ltd. romanizedY20170002309IExact 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: 2026/11/13 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. 2026/11/04Supplement delivery

    Ji Rui Pharmaceuticals (Zhongguo) Co., Ltd. romanized

    JYHB2600275

    Fact date: 2026/11/04 · Publication date: 2026/11/06 · Site observation date: 2026/11/06

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 194 ↗
  2. 2026/09/02Accepted

    Gedeon Richter Plc.

    JYHB2600507

    Fact date: 2026/09/02 · 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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