Last Updated: November 8, 2026

Details for New Drug Application (NDA): 090456

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NDA 090456 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 090456

Tradename:	MYCOPHENOLATE MOFETIL
Applicant:	Strides Pharma
Ingredient:	mycophenolate mofetil
Patents:	0

Pharmacology for NDA: 090456

Suppliers and Packaging for NDA: 090456

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	090456	ANDA	Major Pharmaceuticals	0904-7078	0904-7078-61	100 BLISTER PACK in 1 CARTON (0904-7078-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	090456	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-836	23155-836-01	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (23155-836-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jun 10, 2010	TE:	AB	RLD:	No

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