Viewing data from:

CLOBETASOL PROPIONATE

ANDA

CLOBETASOL PROPIONATE | A074089 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain9 active DMFs4 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVCLOBETASOL PROPIONATE

DMF 68141987

FARMABIOS SPACLOBETASOL PROPIONATE

DMF 83361989

SYMBIOTEC PHARMALAB PRIVATE LTDCLOBETASOL PROPIONATE USP

DMF 208212007

HALCYON LABS PRIVATE LTDCLOBETASOL PROPIONATE USP

DMF 212162008

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHDCLOBETASOL PROPIONATE

DMF 240152010

CURIA SPAIN SAUCLOBETASOL PROPIONATE MICRONIZED

DMF 261912012

ENVEE DRUGS PVT LTDCLOBETASOL PROPIONATE USP

DMF 307522016

RN LABORATORIES EUROPE BVCLOBETASOL PROPIONATE USP (21-CHLORO-9-FLUORO-11, 17-DIHYDROXY-16-METHYLPREGNA-1,4-DIENE3,20-DIONE 17-PROPIONATE)

DMF 344852020

NEWCHEM SPACLOBETASOL PROPIONATE

DMF 428922025

CESQUISA SAInactiveCLOBETASOL PROPIONATE

DMF 80961989

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveCLOBETASOL PROPIONATE

DMF 182022005

MAHIMA LIFE SCIENCES PRIVATE LTDInactiveCLOBETASOL PROPIONATE USP

DMF 226502008

GLAXOSMITHKLINE LLCInactiveCLOBETASOL PROPIONATE

DMF 254442012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 0.05%

0 patents0 exclusivities▴

OINTMENT;TOPICAL | Approved: Feb 16, 1994

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Clobetasol Propionate NDA 074089 applicant name updated from COSETTE to COSETTE PHARMS NC.

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals updated its legal entity name from Cosette Pharmaceuticals Inc to Cosette Pharmaceuticals NC Laboratories LLC for clobetasol propionate NDA 074089.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC