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FLUOCINONIDE EMULSIFIED BASE

ANDA

FLUOCINONIDE | A074204 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain3 active DMFs5 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

TAPI NL BVFLUOCINONIDE

DMF 45911982

TARO PHARMACEUTICAL INDUSTRIES LTDFLUOCINONIDE USP MICRONIZED

DMF 141511999

TAPI NL BVFLUOCINONIDE (NEW PROCESS)

DMF 212612008

ANTIBIOTICOS SPAInactiveFLUOCINONIDE (BULK, NON STERILE, NON-MICRONIZED & MICRONIZED)

DMF 31121978

CESQUISA SAInactiveFLUOCINONIDE

DMF 73841988

FARMABOISInactiveFLUOCINONIDE

DMF 73911988

QUATRUMInactiveFLUOCINONIDE

DMF 74321988

NOBEL CHEMICALS AB DIV FINE CHEMICALS INCInactiveFLUOCINONIDE

DMF 75031988

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

Products (1)

#001 — 0.05%

AB2

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Jun 13, 1995

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated the applicant name for fluocinonide emulsified base (NDA 074204) from "Cosette" to "Cosette Pharms NC."

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals Inc changed its corporate name to Cosette Pharmaceuticals NC Laboratories LLC for NDA 074204 (Fluocinonide Emulsified Base).

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC