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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.

ApplicationSponsorOriginal approvalListings
ANDA 074089COSETTE PHARMS NC1994-02-161
ANDA 074407FOUGERA PHARMS1996-02-231
ANDA 074249SUN PHARMA CANADA1996-07-082
ANDA 074248SUN PHARMA CANADA1996-07-121
ANDA 074392FOUGERA PHARMS INC1996-09-302
ANDA 075027PADAGIS US1997-10-315
ANDA 075057AUROBINDO PHARMA USA1998-08-121
ANDA 075224SUN PHARMA CANADA1998-11-161
ANDA 075391FOUGERA PHARMS1999-02-081
ANDA 075430FOUGERA PHARMS1999-05-261
ANDA 075279SUN PHARMA CANADA1999-05-281
ANDA 075368FOUGERA PHARMS2000-02-151
ANDA 077763PADAGIS ISRAEL2008-03-102
ANDA 090974PADAGIS ISRAEL2012-08-094
ANDA 201402PADAGIS ISRAEL2012-08-142
ANDA 206075NOVEL LABS INC2015-11-232
ANDA 206378ZYDUS PHARMS2017-02-162
ANDA 208933GLENMARK SPECLT2017-03-203
ANDA 209411BEACH PRODS2017-08-212
ANDA 209361MACLEODS PHARMS2017-10-252
ANDA 210199ZYDUS PHARMS2017-10-272
NDA 209483PRIMUS PHARMS2017-11-282
ANDA 209701XIROMED2018-04-173
ANDA 210190GLENMARK PHARMS LTD2018-04-181
ANDA 208841NOVEL LABS INC2018-05-042
ANDA 210034XIROMED2018-06-157
ANDA 211256AMNEAL2018-12-263
ANDA 211800ALEMBIC2019-03-043
ANDA 205249ZYDUS LIFESCIENCES2019-09-242
ANDA 211494SAPTALIS PHARMS2019-10-023
ANDA 211191ALEMBIC2019-10-022
ANDA 212881ALEMBIC2019-10-212
ANDA 211295ENCUBE2019-11-1512
ANDA 213291ALEMBIC2020-01-272
ANDA 213290ALEMBIC2020-05-182
ANDA 212982ENCUBE2020-08-2810
ANDA 214867SUN PHARMA CANADA2021-03-252
ANDA 215838ALEMBIC2022-04-212
ANDA 215990MACLEODS PHARMS2023-12-283
NDA 218158HARROW EYE2024-03-042

Showing 40 of 57 applications.

Official labeling on DailyMed

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.