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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021341
Company: GD SEARLE

Other Important Information from FDA

Products on NDA 021341

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BEXTRA	VALDECOXIB	10MG	TABLET;ORAL	Discontinued	None	No	No
BEXTRA	VALDECOXIB	20MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021341

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/16/2001	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21341lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-341_Bextra_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-341_Bextra.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/24/2004	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21341lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21341ltr.pdf
04/23/2004	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21341se8-003_bextra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21341se8-003ltr.pdf
11/01/2002	SUPPL-2	Labeling	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21341slr002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021341_S002_BEXTRATOC.cfml

Labels for NDA 021341

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/24/2004	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21341lbl.pdf
04/23/2004	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21341se8-003_bextra_lbl.pdf
11/16/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21341lbl.pdf

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