Infliximab
Product Approval Information - Licensing Action
Proper name: Infliximab
Tradename: Remicade
Manufacturer: Centocor, Inc, Malvern, PA, License #1242
Indication for Use: Reduction in signs and symptoms of rheumatoid arthritis in patients who have had an inadequate response to methotrexate
Approval Date: 11/10/99
Type of submission: Biologics license application supplement
Approval Letter
(Text),
(PDF)
Label (PDF)
Statistical Review (PDF)
Pharmacology Review (PDF)
Clinical Pharmacology Review (PDF)
Clinical Review (PDF)
Last Updated: 12/6/2001
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Updated: September 25, 2003 |