Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020429
Company: WYETH CONS

Products on NDA 020429

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ORUDIS KT	KETOPROFEN	12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020429

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.