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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 214871

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NDA 214871 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, Lannett Co Inc, 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 forty-nine NDAs. It is available from twenty-nine 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. Seven suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.

Summary for 214871

Tradename:	MYCOPHENOLATE MOFETIL
Applicant:	Amneal
Ingredient:	mycophenolate mofetil
Patents:	0

Pharmacology for NDA: 214871

Suppliers and Packaging for NDA: 214871

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	FOR SUSPENSION;ORAL	214871	ANDA	Amneal Pharmaceuticals NY LLC	60219-1595	60219-1595-2	1 BOTTLE, PLASTIC in 1 CARTON (60219-1595-2) / 225 mL in 1 BOTTLE, PLASTIC
MYCOPHENOLATE MOFETIL	mycophenolate mofetil	FOR SUSPENSION;ORAL	214871	ANDA	Amneal Pharmaceuticals NY LLC	69238-1595	69238-1595-2	1 BOTTLE, PLASTIC in 1 CARTON (69238-1595-2) / 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 2, 2021	TE:	AB	RLD:	No

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