Infliximab
Product Approval Information - Licensing Action
Proper name: Infliximab
Tradename: Remicade
Manufacturer: Centocor, Inc, Malvern, PA,
License #1242
Indication for Use: Improving physical function in patients
with moderately to severely active rheumatoid arthritis who have had
an inadequate response to methotrexate
Approval Date: 2/27/2002
Type of submission: Biologics license application
Approval Letter - (PDF)
Label - (PDF)
Last Updated: 3/29/2002
Approval Letter -
(Text)
Last Updated: 4/3/2003
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Date created: September 24, 2003 |