Last Updated: November 8, 2026

Details for New Drug Application (NDA): 210181

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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, 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, Neocubes Pharma, Quagen, 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 fifty NDAs. It is available from thirty suppliers. Additional details are available on the MYCOPHENOLATE MOFETIL profile page.

The generic ingredient in MYCOPHENOLATE MOFETIL is mycophenolate mofetil hydrochloride. There are two 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 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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