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Last Updated: January 29, 2026

Details for New Drug Application (NDA): 211374

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NDA 211374 describes MYCOPHENOLATE MOFETIL HYDROCHLORIDE, which is a drug marketed by Amneal, Bpi Labs, Meitheal, Mylan Labs Ltd, Onesource Specialty, Ph Health, Rising, and Zydus Pharms, and is included in eight NDAs. It is available from six suppliers. Additional details are available on the MYCOPHENOLATE MOFETIL HYDROCHLORIDE profile page.

The generic ingredient in MYCOPHENOLATE MOFETIL HYDROCHLORIDE is mycophenolate mofetil hydrochloride. There are thirty-eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.

Summary for 211374

Tradename:	MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Applicant:	Amneal
Ingredient:	mycophenolate mofetil hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	500MG/VIAL
Approval Date:	Mar 5, 2021	TE:		RLD:	No

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