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FLUOCINOLONE ACETONIDE

ANDA

FLUOCINOLONE ACETONIDE | A089525 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain4 active DMFs7 inactive

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

TAPI NL BVFLUOCINOLONE ACETONIDE (PROCESS I)

DMF 44861982

FARMABIOS SPAFLUOCINOLONE ACETONIDE

DMF 173952004

TEVA PHARMACEUTICAL INDUSTRIES LTDFLUOCINOLONE ACETONIDE - PROCESS II

DMF 238752010

HENAN LIHUA PHARMACEUTICAL CO LTDFLUOCINOLONE ACETONIDE

DMF 404062024

DR REDDYS LABORATORIES LTDInactiveFLUOCINOLONE ACETONIDE

DMF 4181961

DR REDDYS LABORATORIES LTDInactiveFLUOCINOLONE ACETONIDE ACETATE

DMF 8061964

ANTIBIOTICOS SPAInactiveFLUOCINOLONE ACETONIDE

DMF 27871976

NOBEL CHEMICALS AB DIV FINE CHEMICALS INCInactiveFLUOCINOLONE ACETONIDE

DMF 29441977

QUATRUMInactiveFLUOCINOLONE ACETONIDE

DMF 73861988

FARMABOISInactiveFLUOCINOLONE ACETONIDE

DMF 74581988

SICOR SPAInactiveFLUOCINOLONE ACETONIDE 1,2-DIHYDRO

DMF 155722001

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

Products (1)

#001 — 0.025%

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Jul 26, 1988

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals North Carolina became the listed applicant for fluocinolone acetonide (NDA 089525).

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals updated its legal entity name from Cosette Pharmaceuticals Inc to Cosette Pharmaceuticals NC Laboratories LLC for the fluocinolone acetonide NDA 089525.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC