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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 065520

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NDA 065520 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-nine 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. Eight suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.

Summary for 065520

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

Pharmacology for NDA: 065520

Suppliers and Packaging for NDA: 065520

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	CAPSULE;ORAL	065520	ANDA	Mylan Pharmaceuticals Inc.	0378-2250	0378-2250-05	500 CAPSULE in 1 BOTTLE, PLASTIC (0378-2250-05)
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	CAPSULE;ORAL	065520	ANDA	Mylan Institutional Inc.	51079-721	51079-721-20	100 BLISTER PACK in 1 CARTON (51079-721-20) / 1 CAPSULE in 1 BLISTER PACK (51079-721-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	May 4, 2009	TE:	AB	RLD:	No

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