Details for New Drug Application (NDA): 065416

NDA 065416 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, Teva Pharms, Zhejiang Hisun Pharm, Zydus Pharms Usa Inc, Amneal, Lannett Co Inc, Teva Pharms Usa, Vistapharm, Apotex, Aurobindo Pharma, Bpi Labs, Endo Operations, Meitheal, Mylan Labs Ltd, Rising, Steriscience Speclts, and Zydus Pharms, and is included in forty-eight 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. Eleven suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.

Summary for 065416

Tradename:	MYCOPHENOLATE MOFETIL
Applicant:	Accord Hlthcare
Ingredient:	mycophenolate mofetil
Patents:	0

Pharmacology for NDA: 065416

Suppliers and Packaging for NDA: 065416

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	065416	ANDA	Accord Healthcare Inc.	16729-019	16729-019-01	100 TABLET in 1 BOTTLE (16729-019-01)
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	065416	ANDA	Accord Healthcare Inc.	16729-019	16729-019-16	500 TABLET in 1 BOTTLE (16729-019-16)

Profile for product number 001

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

Complete Access Available with Subscription