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Infliximab
Product Approval Information - Licensing Action
Proper name: Infliximab
Tradename: Remicade
Manufacturer: Centocor, Inc, Malvern, PA, License #1242
Indication for Use: Reducing signs and symptoms, and inducing and maintaining clinical remission in patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy
Approval Date: 6/28/2002
Type of submission: Biologics license application supplement
Approval Letter -
(PDF)
Label -
(PDF)
Last Updated: 7/3/2002
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Date created: September 24, 2003 |
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