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DESONIDE

ANDA

DESONIDE | A074027 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain3 active DMFs5 inactive

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

TAPI NL BVDESONIDE

DMF 44201982

FARMABIOS SPADESONIDE DRUG SUBSTANCE

DMF 195742006

AARTI PHARMALABS LTDDESONIDE

DMF 229632009

LINSON LTDInactiveDESONIDE

DMF 16711971

ASPEN OSS BVInactiveDESONIDE

DMF 39391980

ER SQUIBB AND SONS INCInactiveDESONIDE

DMF 40081980

NITA PHARMACEUTICAL LTDInactiveDESONIDE (PREDNACINOLONE 16,17 ACETONIDE

DMF 54761984

NEWCHEM SPAInactiveDESONIDE MICRONIZED

DMF 227492009

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

Products (1)

#001 — 0.05%

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Sep 28, 1992

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated its official applicant name to Cosette Pharms NC for desonide NDA 074027.

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals updated the applicant name for desonide (NDA 074027) from Cosette Pharmaceuticals Inc to Cosette Pharmaceuticals NC Laboratories LLC.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC