Viewing data from:

HALOBETASOL PROPIONATE

ANDA

HALOBETASOL PROPIONATE | A077109 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain7 active DMFs2 inactive

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

WAVELENGTH ENTERPRISES LTDHALOBETASOL PROPIONATE

DMF 168562003

STERLING SPAHALOBETASOL PROPIONATE

DMF 168612003

HOVIONE FARMACIENCIA SAHALOBETASOL PROPIONATE

DMF 169532003

TARO PHARMACEUTICAL INDUSTRIES LTDHALOBETASOL PROPIONATE USP, MICRONIZED

DMF 175292004

TRIFARMA SPAHALOBETASOL PROPIONATE

DMF 185662005

SYMBIOTEC PHARMALAB PRIVATE LTDHALOBETASOL PROPIONATE

DMF 194022006

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHDHALOBETASOL PROPIONATE

DMF 309062016

SAFC INCInactiveHALOBETASOL PROPIONATE (HBS)

DMF 163292002

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveHALOBETASOL PROPIONATE

DMF 169442003

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: Jun 14, 2005

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated its applicant name on the Orange Book listing for Halobetasol Propionate (NDA 077109) from "Cosette" to "Cosette Pharms NC."

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals changed its legal entity name to Cosette Pharmaceuticals NC Laboratories LLC for the Halobetasol Propionate NDA 077109.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC