Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English