Last Updated: November 8, 2026

Details for New Drug Application (NDA): 203005

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NDA 203005 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 203005

Tradename:	MYCOPHENOLATE MOFETIL
Applicant:	Alkem Labs Ltd
Ingredient:	mycophenolate mofetil
Patents:	0

Pharmacology for NDA: 203005

Suppliers and Packaging for NDA: 203005

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	FOR SUSPENSION;ORAL	203005	ANDA	Ascend Laboratories, LLC	67877-230	67877-230-22	1 BOTTLE, PLASTIC in 1 CARTON (67877-230-22) / 225 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	200MG/ML
Approval Date:	Nov 14, 2014	TE:	AB	RLD:	No

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