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HYDROCORTISONE VALERATE

ANDA

HYDROCORTISONE VALERATE | A211764 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain3 active DMFs1 inactive

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

LUPIN LTDHYDROCORTISONE VALERATE USP

DMF 311432016

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHDHYDROCORTISONE VALERATE USP

DMF 314232017

TRIFARMA SPAHYDROCORTISONE VALERATE

DMF 333342018

YANGZHOU PHARMACEUTICAL CO LTDInactiveHYDROCORTISONE VALERATE USP

DMF 309712016

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

Products (1)

#001 — 0.2%

0 patents0 exclusivities▴

OINTMENT;TOPICAL | Approved: Mar 4, 2020

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated its applicant name from "Cosette" to "Cosette Pharms NC" for Hydrocortisone Valerate NDA 211764.

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals changed its legal entity name to Cosette Pharmaceuticals NC Laboratories LLC for hydrocortisone valerate NDA 211764.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC