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U.S. Department of Health and Human Services

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Infliximab Product Approval Info - 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 (PDF)

Label (PDF)

Statistical Review (PDF)

Pharmacology Review (PDF)

Clinical Pharmacology Review (PDF)

Clinical Review (PDF)