Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018841
Company: PFIZER

• Medication Guide

Products on NDA 18841

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DAYPRO	OXAPROZIN	600MG	TABLET;ORAL	Discontinued	None	Yes	No

Labels for NDA 018841

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018841s036lbl.pdf
11/09/2022	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018841s034lbl.pdf
04/28/2021	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018841s033lbl.pdf
05/03/2019	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018841s030lbl.pdf
05/09/2016	SUPPL-28	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018841s028lbl.pdf
05/09/2016	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018841s028lbl.pdf
05/09/2016	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018841s028lbl.pdf
06/21/2007	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/18841s022lbl.pdf
01/18/2006	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018841s021lbl.pdf
04/10/2003	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18841slr020_Daypro_lbl.pdf
01/25/2002	SUPPL-16	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18841s12s16lbl.pdf
01/25/2002	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18841s12s16lbl.pdf