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Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 019816

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ORUVAIL	KETOPROFEN	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ORUVAIL	KETOPROFEN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ORUVAIL	KETOPROFEN	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019816

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.

Labels for NDA 019816

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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