mycophenolate mofetil

FDA Drug Profile — Mycophenolate Mofetil, mycophenolate mofetil, MYCOPHENOLATE MOFETIL

Drug Details

Generic Name
mycophenolate mofetil
Brand Names
Mycophenolate Mofetil, mycophenolate mofetil, MYCOPHENOLATE MOFETIL
Application Number
ANDA065520
Sponsor
Mylan Pharmaceuticals Inc.
NDC Codes
19
Dosage Forms
CAPSULE, POWDER, TABLET, TABLET, FILM COATED, INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, POWDER, FOR SUSPENSION
Routes
ORAL, INTRAVENOUS
Active Ingredients
MYCOPHENOLATE MOFETIL

Indications and Usage

1 INDICATIONS AND USAGE 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)