Last Updated: August 9, 2026

Details for New Drug Application (NDA): 065413

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NDA 065413 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, Lannett Co Inc, 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 twenty-seven suppliers. Additional details are available on the MYCOPHENOLATE MOFETIL profile page.

The generic ingredient in MYCOPHENOLATE MOFETIL 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 065413

Tradename:	MYCOPHENOLATE MOFETIL
Applicant:	Hikma
Ingredient:	mycophenolate mofetil
Patents:	0

Pharmacology for NDA: 065413

Suppliers and Packaging for NDA: 065413

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	065413	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0166	0054-0166-25	100 TABLET in 1 BOTTLE (0054-0166-25)
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	065413	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0166	0054-0166-29	500 TABLET in 1 BOTTLE (0054-0166-29)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jul 29, 2008	TE:		RLD:	No

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