Details for New Drug Application (NDA): 212087

NDA 212087 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, Hikma, Jubilant Cadista, Mylan, Sandoz, Strides Pharma, Teva Pharms, Zhejiang Hisun Pharm, Zydus Pharms Usa Inc, Amneal, Hetero Labs Ltd V, 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-six 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. Eleven suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.

Summary for 212087

Tradename:	MYCOPHENOLATE MOFETIL
Applicant:	Concord Biotech Ltd
Ingredient:	mycophenolate mofetil
Patents:	0

Pharmacology for NDA: 212087

Suppliers and Packaging for NDA: 212087

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	212087	ANDA	CONCORD BIOTECH LIMITED	68254-5003	68254-5003-1	30 TABLET in 1 BOTTLE (68254-5003-1)
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	212087	ANDA	CONCORD BIOTECH LIMITED	68254-5003	68254-5003-2	100 TABLET in 1 BOTTLE (68254-5003-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jul 31, 2020	TE:	AB	RLD:	No

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