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TRIAMCINOLONE ACETONIDE

ANDA

TRIAMCINOLONE ACETONIDE | A089795 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain12 active DMFs14 inactive

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

TAPI NL BVTRIAMCINOLONE ACETONIDE

DMF 47121982

FARMABIOS SPATRIAMCINOLONE ACETONIDE

DMF 146932000

TIANJIN TIANYAO PHARMACEUTICALS CO LTDTRIAMCINOLONE ACETONIDE USP

DMF 190962006

CURIA SPAIN SAUTRIAMCINOLONE ACETONIDE STERILE MICRONIZED, USP

DMF 211732007

SYMBIOTEC PHARMALAB PRIVATE LTDTRIAMCINOLONE ACETONIDE USP

DMF 212632008

FARMABIOS SPATRIAMCINOLONE ACETONIDE MICRONIZED STERILE

DMF 215912008

EUROAPI FRANCETRIAMCINOLONE ACETONIDE

DMF 229472009

NEWCHEM SPATRIAMCINOLONE ACETONIDE MICRONIZED

DMF 245432011

CORAL DRUGS PRIVATE LTDTRIAMCINOLONE ACETONIDE

DMF 313572017

SHANDONG SIRUI PHARMACEUTICAL CO LTDTRIAMCINOLONE ACETONIDE

DMF 363132022

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDTRIAMCINOLONE ACETONIDE

DMF 398652024

HENAN LIHUA PHARMACEUTICAL CO LTDTRIAMCINOLONE ACETONIDE

DMF 398972024

ANTIBIOTICOS SPAInactiveTRIAMCINOLONE ACETONIDE

DMF 26511976

PIERREL SPAInactiveTRIAMCINOLONE ACETONIDE

DMF 26551976

MANUFACTURING ENTERPRISES INCInactiveTRIAMCINOLONE ACETONIDE 10%

DMF 27251976

ER SQUIBB AND SONS INCInactiveTRIAMCINOLONE ACETONIDE CONCENTRATE

DMF 27411976

GYMA LABORATORIES AMERICA INCInactiveTRIAMCINOLONE ACETONIDE

DMF 29491977

DIOSYNTH BVInactiveTRIAMCINOLONE ACETONIDE MICRO

DMF 37631980

ROUSSELL UCLAFInactiveTRIAMCINOLONE ACETONIDE

DMF 40851981

COMPANIA ESPANOLA DE SINTESIS QUIMICA SAInactiveTRIAMCINOLONE ACETONIDE USPXX

DMF 41971981

FARMABOISInactiveTRIAMCINOLONE ACETONIDE

DMF 49571983

HOECHST MARION ROUSSEL SAInactiveTRIAMCINOLONE ACETONIDE

DMF 63671986

QUATRUMInactiveTRIAMCINOLONE ACETONIDE

DMF 64971986

PFIZER INCInactiveTRIAMCINOLONE ACETONIDE

DMF 88211990

NANOSYSTEMSInactiveTRIAMCINOLONE ACETONIDE NANOCRYSTAL COLLOIDAL DISPERSION

DMF 121811996

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveTRIAMCINOLONE ACETONIDE MICRONIZED STERILE

DMF 216582008

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

Products (1)

#001 — 0.025%

0 patents0 exclusivities▴

OINTMENT;TOPICAL | Approved: Dec 23, 1988

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Applicant name for triamcinolone acetonide (NDA 089795) changed from COSETTE to COSETTE PHARMS NC.

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 Triamcinolone Acetonide NDA 089795.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC