Details for New Drug Application (NDA): 210181

NDA 210181 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 210181

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

Pharmacology for NDA: 210181

Suppliers and Packaging for NDA: 210181

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	CAPSULE;ORAL	210181	ANDA	CONCORD BIOTECH LIMITED	68254-5000	68254-5000-1	100 CAPSULE in 1 BOTTLE (68254-5000-1)
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	CAPSULE;ORAL	210181	ANDA	CONCORD BIOTECH LIMITED	68254-5000	68254-5000-2	500 CAPSULE in 1 BOTTLE (68254-5000-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	250MG
Approval Date:	Jan 8, 2019	TE:	AB	RLD:	No

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