Viewing data from:

FLUOCINONIDE

ANDA

FLUOCINONIDE | A200735 | FOUGERA PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: VANOS(TE code: AB)

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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 15, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1%

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Jul 14, 2014

No patent or exclusivity listings for this strength.