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Sign in to subscribeAs 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
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.
| Brand name | Applicant (source text) | Application number | Dosage 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 |
| Brand name | Applicant (source text) | Application number | Dosage 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.
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: 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 holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20254398 | 2025/05/27 | 1.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| EXELTIS HEALTHCARE S.L. | LABORATORIOS LEON FARMA, S.A. | 国药准字HJ20240161 | 2024/12/06 | 1.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H19983177 | 2022/09/13 | 0.75mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20058582 | 2022/09/13 | 1.5mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Hua Run Zi Zhu Pharma Co., Ltd. romanized | Hua Run Zi Zhu Pharma Co., Ltd. romanized | 国药准字H10983129 | 2022/08/03 | 0.75mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Hua Run Zi Zhu Pharma Co., Ltd. romanized | Hua Run Zi Zhu Pharma Co., Ltd. romanized | 国药准字H11021372 | 2022/08/03 | 1.5mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Nan Tong Lian Ya Pharma Co., Ltd. romanized | Nan Tong Lian Ya Pharma Co., Ltd. romanized | 国药准字H20223038 | 2022/01/30 | 1.5mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shanghai Xin Yi Tian Ping Pharma Co., Ltd. romanized | Shanghai Xin Yi Tian Ping Pharma Co., Ltd. romanized | 国药准字H20163176 | 2020/09/08 | 1.5mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Shanghai Xin Yi Tian Ping Pharma Co., Ltd. romanized | Shanghai Xin Yi Tian Ping Pharma Co., Ltd. romanized | 国药准字H20093259 | 2020/09/08 | 0.75mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Gedeon Richter Plc. | Gedeon Richter Plc. | H20140728 | 2009/12/24 | 1.5 mg | Imported originator drug | CDE |
| Gedeon Richter Plc. | Gedeon Richter Plc. | H20140053 | 2000/04/26 | 0.75 mg | Imported originator drug | CDE |
| Wuhan Jiu Long Ren Fu Pharma Co., Ltd. romanized | Wuhan Jiu Long Ren Fu Pharma Co., Ltd. romanized | 国药准字H20255422 | 2025/09/09 | 1.5mg | 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: 19 distinct approval numbers and 14 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Beijing Li Ling Heng Tai Pharma Co., Ltd. romanized | 国药准字H19983072 | 0.75mg | Not stated by source | XG03ADZ061A001010100088 | NHSA |
| Beijing Fu Ya Dong Investment Management Co., Ltd. romanized | 国药准字H20184076 | 0.75mg | Not stated by source | XG03ADZ061A001010100200 | NHSA |
| Hua Run Zi Zhu Pharma Co., Ltd. romanized | 国药准字H10983129 | 0.75mg | Not stated by source | XG03ADZ061A001010100225 | NHSA |
| Shanghai Xin Yi Tian Ping Pharma Co., Ltd. romanized | 国药准字H20163176 | 1.5mg | Not stated by source | XG03ADZ061A001010100800 | NHSA |
| Shanghai Xin Yi Tian Ping Pharma Co., Ltd. romanized | 国药准字H20093259 | 0.75mg | Not stated by source | XG03ADZ061A001010100803 | NHSA |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H19983177 | 0.75mg | Not stated by source | XG03ADZ061A001010101161 | NHSA |
| Hua Zhong Pharma Co., Ltd. romanized | 国药准字H20023296 | 0.75mg | Not stated by source | XG03ADZ061A001010101884 | NHSA |
| Sichuan Chuan Da Hua Xi Pharma Co., Ltd. romanized | 国药准字H20113212 | 0.75mg | Not stated by source | XG03ADZ061A001010102129 | NHSA |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20254398 | 1.5mg | Not stated by source | XG03ADZ061A001010107360 | NHSA |
| Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20133081 | 1.5mg | Not stated by source | XG03ADZ061A001010107599 | NHSA |
| Gedeon Richter Plc. | 国药准字HJ20140728 | 1.5mg | Not stated by source | XG03ADZ061A001010179164 | NHSA |
| Shandong Xin Hui Pharma Co., Ltd. romanized | 国药准字H20184036 | 0.75mg | Not stated by source | XG03ADZ061A001010180465 | NHSA |
| Wuhan Jiu Long Ren Fu Pharma Co., Ltd. romanized | 国药准字H20255422 | 1.5mg | Not stated by source | XG03ADZ061A001010183319 | NHSA |
| Nan Tong Lian Ya Pharma Co., Ltd. romanized | 国药准字H20223038 | 1.5 mg | Not stated by source | XG03ADZ061A001010183802 | NHSA |
| Maxmind Pharmaceutical GmbH | 国药准字HJ20240161 | 1.5mg | Not stated by source | XG03ADZ061A001010185381 | NHSA |
| Beijing Li Ling Heng Tai Pharma Co., Ltd. romanized | 国药准字H19983072 | 0.75mg | Not stated by source | XG03ADZ061A001010200088 | NHSA |
| Shanghai Xin Yi Tian Ping Pharma Co., Ltd. romanized | 国药准字H20093259 | 0.75mg | Not stated by source | XG03ADZ061A001010200803 | NHSA |
| Hua Zhong Pharma Co., Ltd. romanized | 国药准字H20023296 | 0.75mg | Not stated by source | XG03ADZ061A001010201884 | NHSA |
| Sichuan Chuan Da Hua Xi Pharma Co., Ltd. romanized | 国药准字H20113212 | 0.75mg | Not stated by source | XG03ADZ061A001010202129 | NHSA |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H20254398 | 1.5mg | Not stated by source | XG03ADZ061A001010207360 | NHSA |
| Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized | 国药准字H20133081 | 1.5mg | Not stated by source | XG03ADZ061A001010207599 | NHSA |
| Shandong Xin Hui Pharma Co., Ltd. romanized | 国药准字H20184036 | 0.75mg | Not stated by source | XG03ADZ061A001010280465 | NHSA |
| Beijing Li Ling Heng Tai Pharma Co., Ltd. romanized | 国药准字H20103026 | 1.5mg | Not stated by source | XG03ADZ061A001020100088 | NHSA |
| Hua Run Zi Zhu Pharma Co., Ltd. romanized | 国药准字H11021372 | 1.5mg | Not stated by source | XG03ADZ061A001020100225 | NHSA |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20058582 | 1.5mg | Not stated by source | XG03ADZ061A001020101161 | NHSA |
| Shandong Xin Hui Pharma Co., Ltd. romanized | 国药准字H20184035 | 1.5mg | Not stated by source | XG03ADZ061A001020180465 | NHSA |
| Beijing Li Ling Heng Tai Pharma Co., Ltd. romanized | 国药准字H20103026 | 1.5mg | Not stated by source | XG03ADZ061A001020200088 | NHSA |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20058582 | 1.5mg | Not stated by source | XG03ADZ061A001020201161 | NHSA |
| Shandong Xin Hui Pharma Co., Ltd. romanized | 国药准字H20184035 | 1.5mg | Not stated by source | XG03ADZ061A001020280465 | NHSA |
| Hua Run Zi Zhu Pharma Co., Ltd. romanized | 国药准字H11021372 | 1.5mg | Not stated by source | XG03ADZ061A001020300225 | 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: 5 filings and 4 distinct first applicants.
Supplement 1 · Generic 4
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Gedeon Richter Plc. | JYHB2600275 | Supplement | 2026/05/14 | Not stated by source | CDE |
| Zhu Zhou Qian Jin Pharma Co., Ltd. romanized; Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized | CYHS2600047 | Generic | 2026/01/06 | Not stated by source | CDE |
| Zhejiang Ai Sheng Pharma Co., Ltd. romanized | CYHS2600035 | Generic | 2026/01/06 | Not stated by source | CDE |
| Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized; Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized | CYHS2504100 | Generic | 2025/11/28 | Not stated by source | CDE |
| Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized; Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized | CYHS2504099 | Generic | 2025/11/28 | Not stated by source | CDE |
Loaded records: 2 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Zhu Zhou Qian Jin Pharma Co., Ltd. romanized; Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized | CYHS2600047 | Generic | 2026/01/06 | Not stated by source | CDE |
| Zhejiang Ai Sheng Pharma Co., Ltd. romanized | CYHS2600035 | Generic | 2026/01/06 | Not stated by source | CDE |
Non-component matches: 7 companies with A status and 2 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 |
|---|---|---|---|---|---|---|
| 左炔诺孕酮 · No verified English name | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | Y20190009601 | A | Exact ingredient | 2025/07/18 | CDE |
| 左炔诺孕酮 · No verified English name | Hunan Ke Yi Xin Biopharmaceuticals Co., Ltd. romanized | Y20220000428 | A | Exact ingredient | 2026/01/17 | CDE |
| 左炔诺孕酮 · No verified English name | INDUSTRIALE CHIMICA SRL | Y20190000943 | A | Exact ingredient | 2025/01/28 | CDE |
| 左炔诺孕酮 · No verified English name | Beijing Shi Ke Yi Feng Bio Technology Development Co., Ltd. romanized | Y20190009473 | A | Exact ingredient | — | CDE |
| 左炔诺孕酮 · No verified English name | Hubei Ge Dian Ren Fu Pharma Co., Ltd. romanized | Y20190007482 | A | Exact ingredient | 2026/07/08 | CDE |
| 左炔诺孕酮 · No verified English name | Qin Huang Dao Zi Zhu Pharma Co., Ltd. romanized | Y20190003154 | A | Exact ingredient | 2026/09/29 | CDE |
| 左炔诺孕酮 · No verified English name | Hua Zhong Pharma Co., Ltd. romanized | Y20190003122 | A | Exact ingredient | 2025/06/11 | CDE |
| 左炔诺孕酮 · No verified English name | Yang Zhou Pharmaceutical Co., Ltd. romanized | Y20190000403 | I | Exact ingredient | 2019/05/28 | CDE |
| 左炔诺孕酮 · No verified English name | Beijing Shi Ke Yi Feng Bio Technology Development Co., Ltd. romanized | Y20170002309 | I | Exact 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.
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.
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 ↗JYHB2600507
Fact date: 2026/09/02 · 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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