Last Updated: November 9, 2026

Details for New Drug Application (NDA): 090419

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NDA 090419 describes MYCOPHENOLATE MOFETIL, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex Corp, Aurobindo Pharma Ltd, Concord Biotech Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Jubilant Cadista, Mylan, Sandoz, Strides Pharma, Strides Pharma Intl, Teva Pharms, Wuxi, Zhejiang Hisun Pharm, Zydus Pharms Usa Inc, Amneal, Neocubes Pharma, Quagen, Rising, Teva Pharms Usa, Vistapharm Llc, Apotex, Aurobindo Pharma, Bpi Labs, Meitheal, Mylan Labs Ltd, Onesource Specialty, Ph Health, and Zydus Pharms, and is included in fifty NDAs. It is available from thirty suppliers. Additional details are available on the MYCOPHENOLATE MOFETIL profile page.

The generic ingredient in MYCOPHENOLATE MOFETIL is mycophenolate mofetil hydrochloride. There are two 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 090419

Tradename:	MYCOPHENOLATE MOFETIL
Applicant:	Apotex Corp
Ingredient:	mycophenolate mofetil
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	Apr 22, 2009	TE:		RLD:	No

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