An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 020776
Company: PFIZER

Medication Guide

Products on NDA 020776

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020776

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020776s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020776Orig1s013ltr.pdf
11/09/2022	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020776s011lbl.pdf
04/28/2021	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020776s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020776Orig1s010ltr.pdf
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-Package Insert, Labeling-Medication Guide, 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

Labels for NDA 020776

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020776s013lbl.pdf
11/09/2022	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020776s011lbl.pdf
04/28/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020776s010lbl.pdf
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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020776s006lbl.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
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

Top