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Sign in to subscribeLevonorgestrel Tablets
Matched- Active ingredients (original)
- LEVONORGESTREL
- Dosage form (original)
- TABLET
- Route (original)
- ORAL
Read these limits
- US patent expiration does not establish Chinese patent expiration. Dates here come from the US Orange Book; Chinese patent status needs separate checking.
- The Orange Book lists holder-submitted patents and does not cover all related patents.
- “Unmatched” means no English ingredient-name counterpart in the Chinese official-name sources loaded here; it does not mean no Chinese approval or filing. A zero count means a Chinese name is matched but no records were found in the loaded source. Source dates appear below.
- This page contains no sales or market-size data and cannot establish development value.
- Names on unmatched rows are the original FDA Orange Book names, without Chinese translation. The same ingredient may have a different generic name in China.
US-approved products
Application numbers, product numbers and original fields are retained. Marketing status is shown as listed in the source.
Earliest approval1999/07/28
ANDA applications21
RLD applicantFOUNDATION CONSUMER HEALTHCARE LLC
Currently marketed products: 14 · Counts FDA prescription and OTC marketing categories as listed; discontinued or unknown categories are excluded.
| Application / product number | Brand name (original) | Applicant (original) | Dosage form (original) | Route (original) | Strength (original) | Earliest approval | RLD / RS | Marketing status (original) | Official source |
|---|---|---|---|---|---|---|---|---|---|
| A078665-001 | LEVONORGESTREL | FOUNDATION CONSUMER HEALTHCARE LLC | TABLET | ORAL | LEVONORGESTREL: 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2009/08/28 | N / N | DISCONTINUED | openFDA ↗ |
| A078666-001 | LEVONORGESTREL | WATSON LABORATORIES INC | TABLET | ORAL | LEVONORGESTREL: 0.75MG | 2009/06/24 | N / N | DISCONTINUED | openFDA ↗ |
| A090740-001 | LEVONORGESTREL | L PERRIGO CO | TABLET | ORAL | LEVONORGESTREL: 0.75MG | 2010/12/30 | N / N | DISCONTINUED | openFDA ↗ |
| A091328-001 | LEVONORGESTREL | LUPIN LTD | TABLET | ORAL | LEVONORGESTREL: 0.75MG | 2013/01/23 | N / N | DISCONTINUED | openFDA ↗ |
| A200670-001 | LEVONORGESTREL | FOUNDATION CONSUMER HEALTHCARE LLC | TABLET | ORAL | LEVONORGESTREL: 1.5MG | 2012/07/12 | N / N | DISCONTINUED | openFDA ↗ |
| A201446-001 | FALLBACK SOLO | LUPIN LTD | TABLET | ORAL | LEVONORGESTREL: 1.5MG | 2014/06/19 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A202246-001 | LEVONORGESTREL | ALVOGEN INC | TABLET | ORAL | LEVONORGESTREL: 1.5MG | 2015/06/05 | N / N | DISCONTINUED | openFDA ↗ |
| A202334-001 | LEVONORGESTREL | PERRIGO R AND D CO | TABLET | ORAL | LEVONORGESTREL: 1.5MG | 2014/08/20 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A202380-001 | LEVONORGESTREL | NAARI PTE LTD | TABLET | ORAL | LEVONORGESTREL: 1.5MG | 2015/05/29 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A202508-001 | LEVONORGESTREL | NOVEL LABORATORIES INC | TABLET | ORAL | LEVONORGESTREL: 1.5MG | 2013/02/22 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A202635-001 | OPCICON ONE-STEP | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET | ORAL | LEVONORGESTREL: 1.5MG | 2014/09/11 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A202684-001 | LEVONORGESTREL | LOTUS PHARMACEUTICAL CO LTD NANTOU PLANT | TABLET | ORAL | LEVONORGESTREL: 0.75MG | 2016/09/02 | N / N | DISCONTINUED | openFDA ↗ |
| A202739-001 | LEVONORGESTREL | XIROMED LLC | TABLET | ORAL | LEVONORGESTREL: 1.5MG | 2014/10/31 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A202740-001 | LEVONORGESTREL | XIROMED LLC | TABLET | ORAL | LEVONORGESTREL: 0.75MG | 2016/09/02 | N / N | DISCONTINUED | openFDA ↗ |
| A204044-001 | LEVONORGESTREL | LABORATOIRE HRA PHARMA | TABLET | ORAL | LEVONORGESTREL: 1.5MG | 2018/07/03 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A205329-001 | LEVONORGESTREL | XIROMED PHARMA ESPANA SL | TABLET | ORAL | LEVONORGESTREL: 1.5MG | 2018/09/18 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A206867-001 | ATHENTIA NEXT | AUROBINDO PHARMA LTD | TABLET | ORAL | LEVONORGESTREL: 1.5MG | 2015/12/08 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A207044-001 | LEVONORGESTREL | GLENMARK PHARMACEUTICALS LTD | TABLET | ORAL | LEVONORGESTREL: 1.5MG | 2016/03/25 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A207660-001 | LEVONORGESTREL | NAARI PTE LTD | TABLET | ORAL | LEVONORGESTREL: 1.5MG | 2019/05/02 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A207976-001 | HER STYLE | NOVAST LABORATORIES LTD | TABLET | ORAL | LEVONORGESTREL: 1.5MG | 2016/03/11 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| A219102-001 | LEVONORGESTREL | ANNORA PHARMA PRIVATE LTD | TABLET | ORAL | LEVONORGESTREL: 1.5MG | 2025/09/30 | N / N | HUMAN OTC DRUG | openFDA ↗ |
| N021045-001 | PLAN B | FOUNDATION CONSUMER HEALTHCARE LLC | TABLET | ORAL | LEVONORGESTREL: 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1999/07/28 | Y / N | DISCONTINUED | openFDA ↗ |
| N021045-002 | PLAN B | FOUNDATION CONSUMER HEALTHCARE LLC | TABLET | ORAL | LEVONORGESTREL: 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2006/08/24 | Y / N | DISCONTINUED | openFDA ↗ |
| N021998-001 | PLAN B ONE-STEP | FOUNDATION CONSUMER HEALTHCARE LLC | TABLET | ORAL | LEVONORGESTREL: 1.5MG | 2009/07/10 | Y / Y | HUMAN OTC DRUG | openFDA ↗ |
Listed US patents
*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.
Latest listed patent expiration—
Substance patent expiration (DS flag)—
This column includes only source rows explicitly flagged DS. A PED row without that flag is not assigned one by this site.
| Application / product number | Patent number | Listed expiration | Substance / product flags | Use code | Delisting request | Official source |
|---|---|---|---|---|---|---|
| Not listed | ||||||
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: —
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| Not listed | |||
Chinese record details
Chinese product landscape ↗The four-zero filter applies only to matched rows: catalog holders, NHSA approval numbers, applications under review, and companies filing generics this year. Unmatched rows have no Chinese counts. 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.
Catalog holders 8
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H202543981.5mg | 2025/05/27 | Official source ↗ |
| EXELTIS HEALTHCARE S.L. | 国药准字HJ202401611.5mg | 2024/12/06 | Official source ↗ |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H199831770.75mg | 2022/09/13 | Official source ↗ |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H200585821.5mg | 2022/09/13 | Official source ↗ |
| Hua Run Zi Zhu Pharma Co., Ltd. romanized | 国药准字H109831290.75mg | 2022/08/03 | Official source ↗ |
| Hua Run Zi Zhu Pharma Co., Ltd. romanized | 国药准字H110213721.5mg | 2022/08/03 | Official source ↗ |
| Nan Tong Lian Ya Pharma Co., Ltd. romanized | 国药准字H202230381.5mg | 2022/01/30 | Official source ↗ |
| Shanghai Xin Yi Tian Ping Pharma Co., Ltd. romanized | 国药准字H201631761.5mg | 2020/09/08 | Official source ↗ |
| Shanghai Xin Yi Tian Ping Pharma Co., Ltd. romanized | 国药准字H200932590.75mg | 2020/09/08 | Official source ↗ |
| Gedeon Richter Plc. | H201407281.5 mg | 2009/12/24 | Official source ↗ |
| Gedeon Richter Plc. | H201400530.75 mg | 2000/04/26 | Official source ↗ |
| Wuhan Jiu Long Ren Fu Pharma Co., Ltd. romanized | 国药准字H202554221.5mg | 2025/09/09 | Official source ↗ |
NHSA approval numbers 19
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Li Ling Heng Tai Pharma Co., Ltd. romanized | 国药准字H199830720.75mg | — | Official source ↗ |
| Beijing Fu Ya Dong Investment Management Co., Ltd. romanized | 国药准字H201840760.75mg | — | Official source ↗ |
| Hua Run Zi Zhu Pharma Co., Ltd. romanized | 国药准字H109831290.75mg | — | Official source ↗ |
| Shanghai Xin Yi Tian Ping Pharma Co., Ltd. romanized | 国药准字H201631761.5mg | — | Official source ↗ |
| Shanghai Xin Yi Tian Ping Pharma Co., Ltd. romanized | 国药准字H200932590.75mg | — | Official source ↗ |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H199831770.75mg | — | Official source ↗ |
| Hua Zhong Pharma Co., Ltd. romanized | 国药准字H200232960.75mg | — | Official source ↗ |
| Sichuan Chuan Da Hua Xi Pharma Co., Ltd. romanized | 国药准字H201132120.75mg | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H202543981.5mg | — | Official source ↗ |
| Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized | 国药准字H201330811.5mg | — | Official source ↗ |
| Gedeon Richter Plc. | 国药准字HJ201407281.5mg | — | Official source ↗ |
| Shandong Xin Hui Pharma Co., Ltd. romanized | 国药准字H201840360.75mg | — | Official source ↗ |
| Wuhan Jiu Long Ren Fu Pharma Co., Ltd. romanized | 国药准字H202554221.5mg | — | Official source ↗ |
| Nan Tong Lian Ya Pharma Co., Ltd. romanized | 国药准字H202230381.5 mg | — | Official source ↗ |
| Maxmind Pharmaceutical GmbH | 国药准字HJ202401611.5mg | — | Official source ↗ |
| Beijing Li Ling Heng Tai Pharma Co., Ltd. romanized | 国药准字H199830720.75mg | — | Official source ↗ |
| Shanghai Xin Yi Tian Ping Pharma Co., Ltd. romanized | 国药准字H200932590.75mg | — | Official source ↗ |
| Hua Zhong Pharma Co., Ltd. romanized | 国药准字H200232960.75mg | — | Official source ↗ |
| Sichuan Chuan Da Hua Xi Pharma Co., Ltd. romanized | 国药准字H201132120.75mg | — | Official source ↗ |
| Guangzhou Lang Sheng Pharma Co., Ltd. romanized | 国药准字H202543981.5mg | — | Official source ↗ |
| Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized | 国药准字H201330811.5mg | — | Official source ↗ |
| Shandong Xin Hui Pharma Co., Ltd. romanized | 国药准字H201840360.75mg | — | Official source ↗ |
| Beijing Li Ling Heng Tai Pharma Co., Ltd. romanized | 国药准字H201030261.5mg | — | Official source ↗ |
| Hua Run Zi Zhu Pharma Co., Ltd. romanized | 国药准字H110213721.5mg | — | Official source ↗ |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H200585821.5mg | — | Official source ↗ |
| Shandong Xin Hui Pharma Co., Ltd. romanized | 国药准字H201840351.5mg | — | Official source ↗ |
| Beijing Li Ling Heng Tai Pharma Co., Ltd. romanized | 国药准字H201030261.5mg | — | Official source ↗ |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H200585821.5mg | — | Official source ↗ |
| Shandong Xin Hui Pharma Co., Ltd. romanized | 国药准字H201840351.5mg | — | Official source ↗ |
| Hua Run Zi Zhu Pharma Co., Ltd. romanized | 国药准字H110213721.5mg | — | Official source ↗ |
Under review 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Gedeon Richter Plc. | JYHB2600275 | 2026/05/14 | Official source ↗ |
| Zhu Zhou Qian Jin Pharma Co., Ltd. romanized; Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized | CYHS2600047 | 2026/01/06 | Official source ↗ |
| Zhejiang Ai Sheng Pharma Co., Ltd. romanized | CYHS2600035 | 2026/01/06 | Official source ↗ |
| Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized; Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized | CYHS2504100 | 2025/11/28 | Official source ↗ |
| Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized; Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized | CYHS2504099 | 2025/11/28 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhu Zhou Qian Jin Pharma Co., Ltd. romanized; Beijing Fa Mo Si Da Pharmaceutical Technology Co., Ltd. romanized | CYHS2600047 | 2026/01/06 | Official source ↗ |
| Zhejiang Ai Sheng Pharma Co., Ltd. romanized | CYHS2600035 | 2026/01/06 | Official source ↗ |
API companies with A status 7
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | Y20190009601 | 2025/07/18 | Official source ↗ |
| Hunan Ke Yi Xin Biopharmaceuticals Co., Ltd. romanized | Y20220000428 | 2026/01/17 | Official source ↗ |
| INDUSTRIALE CHIMICA SRL | Y20190000943 | 2025/01/28 | Official source ↗ |
| Beijing Shi Ke Yi Feng Bio Technology Development Co., Ltd. romanized | Y20190009473 | — | Official source ↗ |
| Hubei Ge Dian Ren Fu Pharma Co., Ltd. romanized | Y20190007482 | 2026/07/08 | Official source ↗ |
| Qin Huang Dao Zi Zhu Pharma Co., Ltd. romanized | Y20190003154 | 2026/09/29 | Official source ↗ |
| Hua Zhong Pharma Co., Ltd. romanized | Y20190003122 | 2025/06/11 | Official source ↗ |
Trial registrations 2025/2026 —
Not loaded
Sources and dates
- FDA Orange Book
- 2026/11/06
- CDE acceptance and review
- 2026/11/13 06:42
- Chemical Drug Catalog
- 2026/11/13 06:39
- API registration records
- 2026/11/13 06:41
- NHSA drug code database
- 2026/10/23
- Trial registry
- 2026/11/13 08:09 · Incomplete coverage
Chinese counts use complete ingredient, dosage-form and route matches. Unmatched and partial rows show name-source matching only and make no finding about Chinese approvals or filings. Trials cover registration-number years 2025/2026 only.
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 52-44 · 2022/03/31
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