Details for New Drug Application (NDA): 204043

NDA 204043 describes MYCOPHENOLATE MOFETIL HYDROCHLORIDE, which is a drug marketed by Amneal, Bpi Labs, Endo Operations, Meitheal, Mylan Labs Ltd, Rising, Steriscience Speclts, and Zydus Pharms, and is included in eight NDAs. It is available from ten 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. Eleven suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.

Summary for 204043

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

Pharmacology for NDA: 204043

Suppliers and Packaging for NDA: 204043

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	204043	ANDA	Akorn	17478-422	17478-422-40	4 VIAL in 1 CARTON (17478-422-40) / 20 mL in 1 VIAL
MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	204043	ANDA	Akorn	17478-957	17478-957-40	4 VIAL in 1 CARTON (17478-957-40) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	500MG/VIAL
Approval Date:	Feb 28, 2017	TE:	AP	RLD:	No

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