Viewing data from:

FLUOCINONIDE

ANDA

FLUOCINONIDE | A211758 | ENCUBE ETHICALS PRIVATE LTD

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 — 0.1%

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Apr 3, 2019

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

ENCUBE acquired ownership of fluocinonide (NDA 211758) from PAI Holdings Pharm.

Old: PAI HOLDINGS PHARM

New: ENCUBE

MODIFIEDApplicant Full Name7/1/2026

ENCUBE Ethicals Private Ltd replaced PAI Holdings LLC DBA Pharmaceutical Associates Inc as the applicant for fluocinonide NDA 211758.

Old: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC

New: ENCUBE ETHICALS PRIVATE LTD