mycophenolate mofetil

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

mycophenolate mofetil is listed in the FDA National Drug Code directory with 16 NDC codes, marketed under brand names including mycophenolate mofetil, MYCOPHENOLATE MOFETIL, Mycophenolate Mofetil. Available dosage forms: capsule, injection, powder, lyophilized, for solution, tablet, powder, for suspension, tablet, film coated.

Drug Details

Generic Name
mycophenolate mofetil
Brand Names
mycophenolate mofetil, MYCOPHENOLATE MOFETIL, Mycophenolate Mofetil
Application Number
ANDA200197
Sponsor
Ascend Laboratories, LLC
NDC Codes
16
Dosage Forms
CAPSULE, INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, TABLET, POWDER, FOR SUSPENSION, TABLET, FILM COATED, POWDER
Routes
ORAL, INTRAVENOUS
Active Ingredients
MYCOPHENOLATE MOFETIL

Indications and Usage

1 INDICATIONS AND USAGE Mycophenolate mofetil for oral suspension (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 )