Last Updated: September 24, 2026

Details for New Drug Application (NDA): 091249

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NDA 091249 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, 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 091249

Tradename:	MYCOPHENOLATE MOFETIL
Applicant:	Alkem Labs Ltd
Ingredient:	mycophenolate mofetil
Patents:	0

Pharmacology for NDA: 091249

Suppliers and Packaging for NDA: 091249

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	091249	ANDA	A-S Medication Solutions	50090-4275	50090-4275-0	180 TABLET, FILM COATED in 1 BOTTLE (50090-4275-0)
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	091249	ANDA	AvPAK	50268-558	50268-558-15	50 BLISTER PACK in 1 BOX (50268-558-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-558-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Nov 4, 2011	TE:	AB	RLD:	No

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