Mycophenolate Mofetil hydrochloride

FDA Drug Profile — Mycophenolate Mofetil, CellCept

Drug Details

Generic Name
Mycophenolate Mofetil hydrochloride
Brand Names
Mycophenolate Mofetil, CellCept
Application Number
ANDA214283
Sponsor
BPI Labs LLC
NDC Codes
2
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Mycophenolate Mofetil [mycophenolate mofetil (MMF)] is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1) ], heart [see Clinical Studies (14.2) ] or liver transplants [see Clinical Studies (14.3) ] , in combination with other immunosuppressants. Mycophenolate Mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. ( 1 )