Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020776
Company: GD SEARLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DAYPRO ALTA OXAPROZIN POTASSIUM 600MG 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
10/17/2002 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20776_Daypro_alta_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20776ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-776_Daypro.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/03/2019 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020776s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020776Orig1s008ltr.pdf
05/09/2016 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020776s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020776Orig1s006ltr.pdf
07/05/2007 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020776s002_ltr.pdf
01/18/2006 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020776s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020776s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/03/2019 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020776s008lbl.pdf
05/09/2016 SUPPL-6 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020776s006lbl.pdf
05/09/2016 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020776s006lbl.pdf
05/09/2016 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020776s006lbl.pdf
01/18/2006 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020776s001lbl.pdf
10/17/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20776_Daypro_alta_lbl.pdf

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