Last Updated: September 24, 2026

Details for New Drug Application (NDA): 200197

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NDA 200197 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 200197

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

Pharmacology for NDA: 200197

Suppliers and Packaging for NDA: 200197

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	CAPSULE;ORAL	200197	ANDA	Major Pharmaceuticals	0904-7466	0904-7466-61	100 BLISTER PACK in 1 CARTON (0904-7466-61) / 1 CAPSULE in 1 BLISTER PACK
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	CAPSULE;ORAL	200197	ANDA	AvPAK	50268-557	50268-557-15	50 BLISTER PACK in 1 BOX (50268-557-15) / 1 CAPSULE in 1 BLISTER PACK (50268-557-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	Jun 13, 2013	TE:	AB	RLD:	No

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