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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 203859

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NDA 203859 describes MYCOPHENOLATE MOFETIL HYDROCHLORIDE, which is a drug marketed by Amneal, Bpi Labs, Meitheal, Mylan Labs Ltd, Onesource Specialty, Ph Health, Rising, and Zydus Pharms, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the MYCOPHENOLATE MOFETIL HYDROCHLORIDE profile page.

The generic ingredient in MYCOPHENOLATE MOFETIL HYDROCHLORIDE is mycophenolate mofetil hydrochloride. There are thirty-eight drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.

Summary for 203859

Tradename:	MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Applicant:	Mylan Labs Ltd
Ingredient:	mycophenolate mofetil hydrochloride
Patents:	0

Pharmacology for NDA: 203859

Suppliers and Packaging for NDA: 203859

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	203859	ANDA	Mylan Institutional LLC	67457-386	67457-386-81	4 VIAL in 1 CARTON (67457-386-81) / 20 mL in 1 VIAL (67457-386-00)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	500MG/VIAL
Approval Date:	Mar 31, 2017	TE:	AP	RLD:	No

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