Viewing data from:

FLUOCINONIDE

ANDA

FLUOCINONIDE | A207554 | SCIEGEN PHARMACEUTICALS INC

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%

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Mar 18, 2019

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDtype7/1/2026

Sciegen Pharms' fluocinonide product (NDA 207554) changed status from discontinued to prescription, indicating resumption of marketing.

Old: DISCN

New: RX

MODIFIEDTE Code7/1/2026

Sciegen Pharms' fluocinonide cream (NDA 207554) received a therapeutic equivalence code of AT, indicating it is therapeutically equivalent to the reference product but differs in its delivery form or other characteristics.

New: AT