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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019816
Company: WYETH PHARMS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORUVAIL KETOPROFEN 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No
ORUVAIL KETOPROFEN 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No
ORUVAIL KETOPROFEN 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/31/2007 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019816s011lbl.pdf
01/18/2006 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018754s027,019816s010lbl.pdf
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