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HYDROCORTISONE VALERATE

ANDA

HYDROCORTISONE VALERATE | A211750 | GLENMARK PHARMACEUTICALS LTD

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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 18, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.2%

0 patents0 exclusivities▴

OINTMENT;TOPICAL | Approved: Dec 14, 2018

No patent or exclusivity listings for this strength.