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Matched- Active ingredients (original)
- MOMETASONE FUROATE
- Dosage form (original)
- CREAM
- Route (original)
- TOPICAL
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 approval1987/05/06
ANDA applications5
RLD applicantORGANON LLC A SUB OF ORGANON AND CO
Currently marketed products: 2 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A076171-001 | MOMETASONE FUROATE | FOUGERA PHARMACEUTICALS INC | CREAM | TOPICAL | MOMETASONE FUROATE: 0.1% | 2005/04/08 | N / N | DISCONTINUED | openFDA ↗ |
| A076591-001 | MOMETASONE FUROATE | CHARTWELL MOLECULAR HOLDINGS LLC | CREAM | TOPICAL | MOMETASONE FUROATE: 0.1% | 2007/04/18 | N / N | DISCONTINUED | openFDA ↗ |
| A076679-001 | MOMETASONE FUROATE | SUN PHARMA CANADA INC | CREAM | TOPICAL | MOMETASONE FUROATE: 0.1% | 2004/12/21 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077447-001 | MOMETASONE FUROATE | COSETTE PHARMACEUTICALS NC LABORATORIES LLC | CREAM | TOPICAL | MOMETASONE FUROATE: 0.1% | 2006/05/22 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078541-001 | MOMETASONE FUROATE | GLENMARK PHARMACEUTICALS INC USA | CREAM | TOPICAL | MOMETASONE FUROATE: 0.1% | 2008/05/28 | N / N | DISCONTINUED | openFDA ↗ |
| N019625-001 | ELOCON | ORGANON LLC A SUB OF ORGANON AND CO | CREAM | TOPICAL | MOMETASONE FUROATE: 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1987/05/06 | N / N | DISCONTINUED | openFDA ↗ |
| N019625-002 | ELOCON | ORGANON LLC A SUB OF ORGANON AND CO | CREAM | TOPICAL | MOMETASONE FUROATE: 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 2013/04/19 | Y / N | DISCONTINUED | 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 0
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| No matching records in this loaded source. | |||
NHSA approval numbers 15
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shanghai Tong Yong Sai Nuo Pharma Co., Ltd. romanized | 国药准字H200408530.1% | — | Official source ↗ |
| Bai Er Pharmaceuticals (Shanghai) Co., Ltd. romanized | 国药准字H199914180.1%(5g:5mg;10g:10mg;15g:15mg) | — | Official source ↗ |
| Chongqing Huapont Pharmaceutical Co., Ltd. | 国药准字H20255360See source | — | Official source ↗ |
| Hubei Heng An Fu Lin Pharma Co., Ltd. romanized | 国药准字H2007417310g:10mg | — | Official source ↗ |
| Hubei Ke Tian Pharma Co., Ltd. romanized | 国药准字H201832210.1%(10g:10mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734010.1%(5g:5mg) | — | Official source ↗ |
| Henan Ling Rui Bio Pharma Co., Ltd. romanized | 国药准字H20133348See source | — | Official source ↗ |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H200506100.1%(5g:5mg),0.1%(10g:10mg) | — | Official source ↗ |
| Hua Run San Jiu (Nanchang) Pharma Co., Ltd. romanized | 国药准字H200740900.1% | — | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20244445See source | — | Official source ↗ |
| Shanghai Tong Yong Sai Nuo Pharma Co., Ltd. romanized | 国药准字H200408530.1% | — | Official source ↗ |
| Bai Er Pharmaceuticals (Shanghai) Co., Ltd. romanized | 国药准字H199914180.1%(5g:5mg;10g:10mg;15g:15mg) | — | Official source ↗ |
| Chongqing Huapont Pharmaceutical Co., Ltd. | 国药准字H20255359See source | — | Official source ↗ |
| Hubei Heng An Fu Lin Pharma Co., Ltd. romanized | 国药准字H2007417310g:10mg | — | Official source ↗ |
| Hubei Ke Tian Pharma Co., Ltd. romanized | 国药准字H201832210.1%(10g:10mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734010.1%(5g:5mg) | — | Official source ↗ |
| Henan Ling Rui Bio Pharma Co., Ltd. romanized | 国药准字H20113466See source | — | Official source ↗ |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H200506100.1%(5g:5mg),0.1%(10g:10mg) | — | Official source ↗ |
| Dian Hong Pharma Group Co., Ltd. romanized | 国药准字H200836235g:5mg | — | Official source ↗ |
| Hubei Ke Tian Pharma Co., Ltd. romanized | 国药准字H201832210.1%(10g:10mg) | — | Official source ↗ |
| Shanghai Tong Yong Sai Nuo Pharma Co., Ltd. romanized | 国药准字H200408530.1% | — | Official source ↗ |
| Bai Er Pharmaceuticals (Shanghai) Co., Ltd. romanized | 国药准字H199914180.1%(5g:5mg;10g:10mg;15g:15mg) | — | Official source ↗ |
| Hubei Heng An Fu Lin Pharma Co., Ltd. romanized | 国药准字H2007417310g:10mg | — | Official source ↗ |
| Hubei Ke Tian Pharma Co., Ltd. romanized | 国药准字H201832210.1%(10g:10mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734010.1%(5g:5mg) | — | Official source ↗ |
| Henan Ling Rui Bio Pharma Co., Ltd. romanized | 国药准字H20113466See source | — | Official source ↗ |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H200506100.1%(5g:5mg),0.1%(10g:10mg) | — | Official source ↗ |
| Hua Run San Jiu (Nanchang) Pharma Co., Ltd. romanized | 国药准字H200740900.1% | — | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20244445See source | — | Official source ↗ |
| Shanghai Tong Yong Sai Nuo Pharma Co., Ltd. romanized | 国药准字H200408530.1% | — | Official source ↗ |
| Hubei Ke Tian Pharma Co., Ltd. romanized | 国药准字H201832210.1%(10g:10mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734010.1%(5g:5mg) | — | Official source ↗ |
| Henan Ling Rui Bio Pharma Co., Ltd. romanized | 国药准字H20113466See source | — | Official source ↗ |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H200506100.1%(5g:5mg),0.1%(10g:10mg) | — | Official source ↗ |
| Shanghai Tong Yong Sai Nuo Pharma Co., Ltd. romanized | 国药准字H200408530.1% | — | Official source ↗ |
| Hubei Ke Tian Pharma Co., Ltd. romanized | 国药准字H201832210.1%(10g:10mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734010.1%(5g:5mg) | — | Official source ↗ |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H200506100.1%(5g:5mg),0.1%(10g:10mg) | — | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H202691110.1%(5g:5mg) | — | Official source ↗ |
| Shanghai Tong Yong Sai Nuo Pharma Co., Ltd. romanized | 国药准字H200408530.1% | — | Official source ↗ |
| Hubei Ke Tian Pharma Co., Ltd. romanized | 国药准字H201832210.1%(10g:10mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734010.1%(5g:5mg) | — | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H202691590.1%(10g:10mg) | — | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H202691590.1%(10g:10mg) | — | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H202691590.1%(10g:10mg) | — | Official source ↗ |
| Hubei Ke Tian Pharma Co., Ltd. romanized | 国药准字H201832210.1%(10g:10mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734010.1%(5g:5mg) | — | Official source ↗ |
| Hubei Ke Tian Pharma Co., Ltd. romanized | 国药准字H201832210.1%(10g:10mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734010.1%(5g:5mg) | — | Official source ↗ |
| Hubei Ke Tian Pharma Co., Ltd. romanized | 国药准字H201832210.1%(10g:10mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734010.1%(5g:5mg) | — | Official source ↗ |
| Hubei Ke Tian Pharma Co., Ltd. romanized | 国药准字H201832210.1%(10g:10mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734010.1%(5g:5mg) | — | Official source ↗ |
| Hubei Ke Tian Pharma Co., Ltd. romanized | 国药准字H201832210.1%(10g:10mg) | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201734010.1%(5g:5mg) | — | Official source ↗ |
| Hubei Ke Tian Pharma Co., Ltd. romanized | 国药准字H201832210.1%(10g:10mg) | — | Official source ↗ |
| Hubei Ke Tian Pharma Co., Ltd. romanized | 国药准字H201832210.1%(10g:10mg) | — | Official source ↗ |
| Hubei Ke Tian Pharma Co., Ltd. romanized | 国药准字H201832210.1%(10g:10mg) | — | Official source ↗ |
| Hubei Ke Tian Pharma Co., Ltd. romanized | 国药准字H201832210.1%(10g:10mg) | — | Official source ↗ |
| Hubei Ke Tian Pharma Co., Ltd. romanized | 国药准字H201832210.1%(10g:10mg) | — | Official source ↗ |
Under review 16
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | CYHS2503492 | 2025/09/23 | Official source ↗ |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | CYHS2503491 | 2025/09/23 | Official source ↗ |
| Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized | CYHS2600743 | 2026/03/30 | Official source ↗ |
| Suzhou Gao Mai Pharma Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd | CYHS2601375 | 2026/06/11 | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2600184 | 2026/01/15 | Official source ↗ |
| Guangdong Ren Xiang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2600081 | 2026/01/08 | Official source ↗ |
| Guangdong Ren Xiang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2600080 | 2026/01/08 | Official source ↗ |
| Guangdong Ren Xiang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2600079 | 2026/01/08 | Official source ↗ |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2504477 | 2025/12/30 | Official source ↗ |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | CYHS2503539 | 2025/09/28 | Official source ↗ |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | CYHS2503538 | 2025/09/28 | Official source ↗ |
| Zhejiang Huan Ling Pharmaceuticals Technology Co., Ltd. romanized | CYHS2503378 | 2025/09/12 | Official source ↗ |
| Zhejiang Huan Ling Pharmaceuticals Technology Co., Ltd. romanized | CYHS2503377 | 2025/09/12 | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | CYHS2602599 | 2026/10/22 | Official source ↗ |
| Hunan Ben Cao Pharmaceutical Co., Ltd. romanized; Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | CYHB2602038 | 2026/11/10 | Official source ↗ |
| Hunan Ben Cao Pharmaceutical Co., Ltd. romanized; Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | CYHB2602037 | 2026/11/10 | Official source ↗ |
Generic-filing companies this year 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized | CYHS2600743 | 2026/03/30 | Official source ↗ |
| Suzhou Gao Mai Pharma Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd | CYHS2601375 | 2026/06/11 | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2600184 | 2026/01/15 | Official source ↗ |
| Guangdong Ren Xiang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2600081 | 2026/01/08 | Official source ↗ |
| Guangdong Ren Xiang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2600080 | 2026/01/08 | Official source ↗ |
| Guangdong Ren Xiang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2600079 | 2026/01/08 | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | CYHS2602599 | 2026/10/22 | Official source ↗ |
API companies with A status 15
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Bo Ze Ge Lin (Shandong) Pharma Co., Ltd. romanized | Y20240000274 | 2026/03/06 | Official source ↗ |
| Henan Li Hua Pharmaceutical Co., Ltd. romanized | Y20240000595 | 2026/02/02 | Official source ↗ |
| Shandong Si Rui Pharma Co., Ltd. romanized | Y20240000435 | 2025/11/10 | Official source ↗ |
| Bo Ze Ge Lin (Shandong) Pharma Co., Ltd. romanized | Y20240000273 | 2026/05/20 | Official source ↗ |
| Sterling.S.p.A | Y20230001259 | 2026/10/21 | Official source ↗ |
| Chongqing Sheng Kai Pharmaceutical Co., Ltd. romanized | Y20230001358 | 2025/04/22 | Official source ↗ |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | Y20230001020 | 2025/01/15 | Official source ↗ |
| Ao Rui Te Pharma Co., Ltd. romanized | Y20220001115 | 2024/06/28 | Official source ↗ |
| Shandong Rui Shun Pharma Co., Ltd. romanized | Y20220000719 | 2026/06/19 | Official source ↗ |
| AVIK PHARMACEUTICAL LTD. | Y20210000968 | 2023/11/02 | Official source ↗ |
| Shandong Rui Shun Pharma Co., Ltd. romanized | Y20210000879 | 2026/06/12 | Official source ↗ |
| CIPLA LTD. | Y20190001032 | 2026/02/07 | Official source ↗ |
| Jin Yao Pharma Co., Ltd. romanized | Y20190009768 | 2026/04/04 | Official source ↗ |
| Shanghai Xin Hua Lian Pharmaceutical Co., Ltd. romanized | Y20190008525 | 2024/11/28 | Official source ↗ |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | Y20190007547 | 2026/03/25 | Official source ↗ |
| Wavelength Enterprises Ltd. | Y20180001760 | 2022/09/27 | Official source ↗ |
| MSD International GmbH（Singapore Branch） | Y20170001657 | 2025/10/14 | Official source ↗ |
| Hubei Heng An Fu Lin Pharma Co., Ltd. romanized | Y20170001175 | 2023/12/08 | 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.
Formulation crosswalk to CREAM / TOPICAL, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-057. Chinese Pharmacopoeia general chapter 0109
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 29-126 · 2022/06/16
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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