Infliximab
Product 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
Approval Letter -
(Text)
Last Updated: 4/3/2003
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Date created: September 24, 2003 |