Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018754
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORUDIS KETOPROFEN 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
ORUDIS KETOPROFEN 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
ORUDIS KETOPROFEN 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No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
01/09/1986 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018754Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/18/2006 SUPPL-27 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018754s027_019816s010ltr.pdf
08/18/2003 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18754slr026ltr.pdf
08/05/1997 SUPPL-25 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/18-754S025.pdf
02/08/1995 SUPPL-24 Labeling

Label is not available on this site.

07/11/1994 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1994 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

02/17/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/06/1994 SUPPL-18 Efficacy-New Indication

Label is not available on this site.

10/26/1988 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/05/1989 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/16/1990 SUPPL-13 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/11/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/18/1988 SUPPL-11 Labeling

Label is not available on this site.

09/05/1990 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/05/1989 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/23/1987 SUPPL-7 Labeling

Label is not available on this site.

04/10/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/16/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/31/1987 SUPPL-4 Labeling

Label is not available on this site.

07/31/1987 SUPPL-3 Efficacy-New Indication

Label is not available on this site.

03/17/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/27/1986 SUPPL-1 Labeling

Label is not available on this site.

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