Infliximab Approval Information - Licensing Action

Proper name: Infliximab
Tradename: Remicade
Manufacturer: Centocor, Inc, Malvern, PA, License #1242
Indication for Use: Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing Crohn’s disease 
Approval Date: 4/1/2003
Type of submission: Biologics license application supplement