Drugs@FDA: FDA Approved Drug Products

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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ORUVAIL KETOPROFEN 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No
ORUVAIL KETOPROFEN 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No
ORUVAIL KETOPROFEN 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/24/1993 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/31/2007 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019816s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019816s011ltr.pdf
01/18/2006 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018754s027,019816s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018754s027_019816s010ltr.pdf
03/13/2009 SUPPL-8 Labeling

Label is not available on this site.

08/05/1997 SUPPL-7 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18-754S025.pdf
03/21/1996 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/21/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/10/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/08/1995 SUPPL-2 Labeling

Label is not available on this site.

02/08/1995 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

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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