Last Updated: May 10, 2026

Details for New Drug Application (NDA): 065521

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NDA 065521 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 forty-nine NDAs. It is available from twenty-eight 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 065521

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

Pharmacology for NDA: 065521

Suppliers and Packaging for NDA: 065521

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	065521	ANDA	Mylan Pharmaceuticals Inc.	0378-4472	0378-4472-05	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4472-05)
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	065521	ANDA	Aphena Pharma Solutions - Tennessee, LLC	71610-033	71610-033-53	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-033-53)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	May 4, 2009	TE:	AB	RLD:	No

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