Details for New Drug Application (NDA): 216390

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NDA 216390 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 six suppliers. Additional details are available on the MYCOPHENOLATE MOFETIL HYDROCHLORIDE profile page.

The generic ingredient in MYCOPHENOLATE MOFETIL HYDROCHLORIDE is mycophenolate mofetil hydrochloride. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.

Summary for 216390

Tradename:	MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Applicant:	Onesource Specialty
Ingredient:	mycophenolate mofetil hydrochloride
Patents:	0

Pharmacology for NDA: 216390

Suppliers and Packaging for NDA: 216390

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	216390	ANDA	ARMAS PHARMACEUTICALS INC	72485-415	72485-415-04	4 VIAL in 1 CARTON (72485-415-04) / 20 mL in 1 VIAL
MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	216390	ANDA	ONESOURCE SPECIALTY PHARMA LIMITED	83270-000	83270-000-04	4 VIAL in 1 CARTON (83270-000-04) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	500MG/VIAL
Approval Date:	Dec 23, 2022	TE:	AP	RLD:	No

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