Active ingredient
Clobetasol
121 finished FDA listings contain Clobetasol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CLOBETASOL PROPIONATE
- Dosage forms
- Aerosol, Foam, Cream, For Suspension, Gel, Lotion, Ointment, Shampoo, Solution, Spray, Suspension/ Drops
- Routes
- Ophthalmic, Topical
- Manufacturers / labelers
- 45
- Strengths listed
- .05 g/100ml · .05 g/ml · .25 mg/g · .4625 mg/ml · .5 mg/g · .5 mg/ml
- Brand names in FDA listings
- Byqlovi, Clobetasol Propionate, Clobetasol Propionate (Emollient), Clobetasol Propionate Anda, Clobetasol Propionate Cream 0.05% Clobetasol Propionate Cream 0.05%, Clobetasol Propionate Cream Usp, 0.05% Clobetasol Propionate Cream Usp, 0.05%, Clobetasol Propionate Cream, 0.05% Clobetasol Propionate Cream, 0.05%, Clobetasol Propionate Emollient Formulation, Clodan, Impoyz, Tovet (Emollient Formulation)
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2590
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 074089 | COSETTE PHARMS NC | 1994-02-16 | 1 |
| ANDA 074407 | FOUGERA PHARMS | 1996-02-23 | 1 |
| ANDA 074249 | SUN PHARMA CANADA | 1996-07-08 | 2 |
| ANDA 074248 | SUN PHARMA CANADA | 1996-07-12 | 1 |
| ANDA 074392 | FOUGERA PHARMS INC | 1996-09-30 | 2 |
| ANDA 075027 | PADAGIS US | 1997-10-31 | 5 |
| ANDA 075057 | AUROBINDO PHARMA USA | 1998-08-12 | 1 |
| ANDA 075224 | SUN PHARMA CANADA | 1998-11-16 | 1 |
| ANDA 075391 | FOUGERA PHARMS | 1999-02-08 | 1 |
| ANDA 075430 | FOUGERA PHARMS | 1999-05-26 | 1 |
| ANDA 075279 | SUN PHARMA CANADA | 1999-05-28 | 1 |
| ANDA 075368 | FOUGERA PHARMS | 2000-02-15 | 1 |
| ANDA 077763 | PADAGIS ISRAEL | 2008-03-10 | 2 |
| ANDA 090974 | PADAGIS ISRAEL | 2012-08-09 | 4 |
| ANDA 201402 | PADAGIS ISRAEL | 2012-08-14 | 2 |
| ANDA 206075 | NOVEL LABS INC | 2015-11-23 | 2 |
| ANDA 206378 | ZYDUS PHARMS | 2017-02-16 | 2 |
| ANDA 208933 | GLENMARK SPECLT | 2017-03-20 | 3 |
| ANDA 209411 | BEACH PRODS | 2017-08-21 | 2 |
| ANDA 209361 | MACLEODS PHARMS | 2017-10-25 | 2 |
| ANDA 210199 | ZYDUS PHARMS | 2017-10-27 | 2 |
| NDA 209483 | PRIMUS PHARMS | 2017-11-28 | 2 |
| ANDA 209701 | XIROMED | 2018-04-17 | 3 |
| ANDA 210190 | GLENMARK PHARMS LTD | 2018-04-18 | 1 |
| ANDA 208841 | NOVEL LABS INC | 2018-05-04 | 2 |
| ANDA 210034 | XIROMED | 2018-06-15 | 7 |
| ANDA 211256 | AMNEAL | 2018-12-26 | 3 |
| ANDA 211800 | ALEMBIC | 2019-03-04 | 3 |
| ANDA 205249 | ZYDUS LIFESCIENCES | 2019-09-24 | 2 |
| ANDA 211494 | SAPTALIS PHARMS | 2019-10-02 | 3 |
| ANDA 211191 | ALEMBIC | 2019-10-02 | 2 |
| ANDA 212881 | ALEMBIC | 2019-10-21 | 2 |
| ANDA 211295 | ENCUBE | 2019-11-15 | 12 |
| ANDA 213291 | ALEMBIC | 2020-01-27 | 2 |
| ANDA 213290 | ALEMBIC | 2020-05-18 | 2 |
| ANDA 212982 | ENCUBE | 2020-08-28 | 10 |
| ANDA 214867 | SUN PHARMA CANADA | 2021-03-25 | 2 |
| ANDA 215838 | ALEMBIC | 2022-04-21 | 2 |
| ANDA 215990 | MACLEODS PHARMS | 2023-12-28 | 3 |
| NDA 218158 | HARROW EYE | 2024-03-04 | 2 |
Showing 40 of 57 applications.
Official labeling on DailyMed
- CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% (CLOBETASOL PROPIONATE CREAM USP, 0.05%) CREAM [REMEDYREPACK INC.] · version 4 · 2026-09-10
- CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% (CLOBETASOL PROPIONATE CREAM USP, 0.05%) CREAM [BRYANT RANCH PREPACK] · version 105 · 2026-08-31
- CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE OINTMENT USP, 0.05%) OINTMENT [BRYANT RANCH PREPACK] · version 107 · 2026-08-28
- CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE OINTMENT USP, 0.05%) OINTMENT [BRYANT RANCH PREPACK] · version 101 · 2026-08-27
- CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE OINTMENT USP, 0.05%) OINTMENT [BRYANT RANCH PREPACK] · version 101 · 2026-08-27
- CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE OINTMENT USP, 0.05%) OINTMENT [BRYANT RANCH PREPACK] · version 101 · 2026-08-27
- CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE OINTMENT USP, 0.05%) OINTMENT [BRYANT RANCH PREPACK] · version 101 · 2026-08-27
- CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% (CLOBETASOL PROPIONATE CREAM USP, 0.05%) CREAM [BRYANT RANCH PREPACK] · version 101 · 2026-08-26
- CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE OINTMENT USP, 0.05%) OINTMENT [BRYANT RANCH PREPACK] · version 107 · 2026-08-11
- CLOBETASOL PROPIONATE SOLUTION [ENCUBE ETHICALS, INC.] · version 3 · 2026-08-11
- CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE OINTMENT USP, 0.05%) OINTMENT [BRYANT RANCH PREPACK] · version 110 · 2026-08-10
- CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE OINTMENT USP, 0.05%) OINTMENT [BRYANT RANCH PREPACK] · version 109 · 2026-08-10
Showing the 12 most recent of 114 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.