Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020429
Company: WYETH CONS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORUDIS KT KETOPROFEN 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
10/06/1995 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
09/10/2004 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20429s008ltr.pdf
08/30/2004 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20429s007ltr.pdf
02/20/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

08/23/2000 SUPPL-4 Labeling

Label is not available on this site.

10/14/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/26/1995 SUPPL-2 Labeling

Label is not available on this site.

11/03/1995 SUPPL-1 Labeling

Label is not available on this site.

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