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U.S. Department of Health and Human Services

Drugs

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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)

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