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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 214283

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NDA 214283 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 214283

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

Pharmacology for NDA: 214283

Suppliers and Packaging for NDA: 214283

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	214283	ANDA	BPI Labs LLC	54288-141	54288-141-04	4 VIAL in 1 CARTON (54288-141-04) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	500MG/VIAL
Approval Date:	Jun 1, 2023	TE:	AP	RLD:	No

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