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Sign in to subscribeFluticasone Propionate Cream
Matched- Active ingredients (original)
- FLUTICASONE PROPIONATE
- 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 approval1990/12/18
ANDA applications5
RLD applicantFOUGERA PHARMACEUTICALS LLC
Currently marketed products: 4 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A076451-001 | FLUTICASONE PROPIONATE | FOUGERA PHARMACEUTICALS INC | CREAM | TOPICAL | FLUTICASONE PROPIONATE: 0.05% | 2004/05/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A076633-001 | FLUTICASONE PROPIONATE | ENCUBE ETHICALS PRIVATE LTD | CREAM | TOPICAL | FLUTICASONE PROPIONATE: 0.05% | 2004/05/14 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A076793-001 | FLUTICASONE PROPIONATE | PADAGIS ISRAEL PHARMACEUTICALS LTD | CREAM | TOPICAL | FLUTICASONE PROPIONATE: 0.05% | 2004/05/14 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A076865-001 | FLUTICASONE PROPIONATE | NESHER PHARMACEUTICALS USA LLC | CREAM | TOPICAL | FLUTICASONE PROPIONATE: 0.05% | 2004/09/10 | N / N | DISCONTINUED | openFDA ↗ |
| A077055-001 | FLUTICASONE PROPIONATE | COSETTE PHARMACEUTICALS NC LABORATORIES LLC | CREAM | TOPICAL | FLUTICASONE PROPIONATE: 0.05% | 2006/06/30 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N019958-001 | CUTIVATE | FOUGERA PHARMACEUTICALS LLC | CREAM | TOPICAL | FLUTICASONE PROPIONATE: 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1990/12/18 | 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 12
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Chongqing Huapont Pharmaceutical Co., Ltd. | 国药准字H202545890.05%(15g:7.5mg) | — | Official source ↗ |
| Hubei Heng An Fu Lin Pharma Co., Ltd. romanized | 国药准字H201035010.05% | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201733460.05%(15g:7.5mg) | — | Official source ↗ |
| Hebei Xin Zhang Yao Co., Ltd. romanized | 国药准字H202643440.05%(15g:7.5mg) | — | Official source ↗ |
| Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized | 国药准字H201732700.05％ | — | Official source ↗ |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H201033370.05% | — | Official source ↗ |
| Ao Mei Pharmaceutical Factory romanized | 国药准字HC201500210.05%[(1)5g:2.5mg；(2)10g:5mg；(3)15g:7.5mg | — | Official source ↗ |
| Glaxo Wellcome UK Limited | H2013043115g:7.5mg(0.05%) | — | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H202444390.05％(15g∶7.5mg) | — | Official source ↗ |
| Jiangsu Ziyond Pharmaceutical Co., Ltd. | 国药准字H202538140.05%(15g:7.5mg) | — | Official source ↗ |
| Hubei Heng An Fu Lin Pharma Co., Ltd. romanized | 国药准字H201035010.05% | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201733460.05%(15g:7.5mg) | — | Official source ↗ |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H201033370.05% | — | Official source ↗ |
| Ao Mei Pharmaceutical Factory Co., Ltd. romanized | 国药准字HC201500220.05%[(1)5g:2.5mg;(2)10g:5mg;(3)15g:7.5mg;(4)20g: | — | Official source ↗ |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H202582130.05%(20g∶10mg) | — | Official source ↗ |
| Hubei Heng An Fu Lin Pharma Co., Ltd. romanized | 国药准字H201035010.05% | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201733460.05%(15g:7.5mg) | — | Official source ↗ |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H201033370.05% | — | Official source ↗ |
| Ao Mei Pharmaceutical Factory romanized | 国药准字HC201500210.05%[(1)5g:2.5mg；(2)10g:5mg；(3)15g:7.5mg | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201733460.05%(15g:7.5mg) | — | Official source ↗ |
| Hubei Heng An Fu Lin Pharma Co., Ltd. romanized | 国药准字H201035010.05% | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201733460.05%(15g:7.5mg) | — | Official source ↗ |
| Ao Mei Pharmaceutical Factory Co., Ltd. romanized | 国药准字HC201500220.05%[(1)5g:2.5mg;(2)10g:5mg;(3)15g:7.5mg;(4)20g: | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201733460.05%(15g:7.5mg) | — | Official source ↗ |
| Ao Mei Pharmaceutical Factory Co., Ltd. romanized | 国药准字HC201500220.05%[(1)5g:2.5mg;(2)10g:5mg;(3)15g:7.5mg;(4)20g: | — | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H201733460.05%(15g:7.5mg) | — | Official source ↗ |
Under review 12
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Fu Yuan Pharma Co., Ltd. romanized | CYHB2601871 | 2026/10/13 | Official source ↗ |
| Chongqing Huapont Pharmaceutical Co., Ltd. | CYHB2601651 | 2026/08/28 | Official source ↗ |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2600577 | 2026/02/28 | Official source ↗ |
| Guangdong Ren Xiang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2600360 | 2026/02/04 | Official source ↗ |
| Guangdong Ren Xiang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2600359 | 2026/02/04 | Official source ↗ |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | CYHS2504507 | 2025/12/31 | Official source ↗ |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2504470 | 2025/12/30 | Official source ↗ |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2504469 | 2025/12/30 | Official source ↗ |
| Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized | CYHS2503797 | 2025/10/28 | Official source ↗ |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | CYHS2503783 | 2025/10/24 | Official source ↗ |
| Zhejiang Hua Hai Pharmaceutical Technology Co., Ltd. romanized | CYHS2503638 | 2025/10/11 | Official source ↗ |
| Zhejiang Zhi Xin Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | CYHS2501501 | 2025/04/19 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2600577 | 2026/02/28 | Official source ↗ |
| Guangdong Ren Xiang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2600360 | 2026/02/04 | Official source ↗ |
| Guangdong Ren Xiang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2600359 | 2026/02/04 | Official source ↗ |
API companies with A status 18
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Glaxo Wellcome Manufacturing Pte Ltd | Y20230001274 | 2025/12/05 | Official source ↗ |
| INDUSTRIALE CHIMICA S.R.L. | Y20230000326 | 2026/03/07 | Official source ↗ |
| Bo Ze Ge Lin (Shandong) Pharma Co., Ltd. romanized | Y20230000446 | 2025/04/16 | Official source ↗ |
| CIPLA LIMITED | Y20230000328 | 2025/12/13 | Official source ↗ |
| VAMSI LABS LTD. | Y20230000256 | 2025/09/22 | Official source ↗ |
| Henan Li Hua Pharmaceutical Co., Ltd. romanized | Y20200001241 | 2025/08/01 | Official source ↗ |
| Shandong Si Rui Pharma Co., Ltd. romanized | Y20200000871 | 2024/05/30 | Official source ↗ |
| Glaxo Wellcome Manufacturing Pte Ltd | Y20200000383 | 2023/01/04 | Official source ↗ |
| Sichuan Ren An Pharma Co., Ltd. romanized | Y20200000487 | 2026/06/08 | Official source ↗ |
| Jin Yao Pharma Co., Ltd. romanized | Y20190008858 | 2026/03/21 | Official source ↗ |
| Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanized | Y20190007593 | 2024/06/06 | Official source ↗ |
| Ao Rui Te Pharma Co., Ltd. romanized | Y20190007020 | 2022/10/28 | Official source ↗ |
| Sterling S.p.A. | Y20180000012 | 2026/08/30 | Official source ↗ |
| Hubei Heng An Fu Lin Pharma Co., Ltd. romanized | Y20170001421 | 2026/07/14 | Official source ↗ |
| Shandong Rui Shun Pharma Co., Ltd. romanized | Y20170001404 | 2026/05/20 | Official source ↗ |
| Wuhan Nuo An Pharma Co., Ltd. romanized | Y20170000801 | 2026/02/07 | Official source ↗ |
| Hubei Ge Dian Ren Fu Pharma Co., Ltd. romanized | Y20170000546 | 2023/05/23 | Official source ↗ |
| Chongqing Sheng Kai Pharmaceutical Co., Ltd. romanized | Y20170000171 | 2025/04/17 | Official source ↗ |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | Y20170000025 | 2024/08/07 | 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 ↗ · 26-1 · 2022/10/11
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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