Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018147
Company: PFIZER

• Medication Guide

Products on NDA 18147

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FELDENE	PIROXICAM	10MG	CAPSULE;ORAL	Prescription	AB	Yes	No
FELDENE	PIROXICAM	20MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Labels for NDA 018147

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/09/2022	SUPPL-52	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018147_S052LBL.pdf
04/28/2021	SUPPL-50	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018147s050lbl.pdf
05/03/2019	SUPPL-48	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018147s048lbl.pdf
05/09/2016	SUPPL-44	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018147s044lbl.pdf
05/09/2016	SUPPL-44	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018147s044lbl.pdf
05/09/2016	SUPPL-44	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018147s044lbl.pdf
02/27/2015	SUPPL-42	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf
02/27/2015	SUPPL-40	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf
02/27/2015	SUPPL-39	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf
02/27/2015	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf
02/27/2015	SUPPL-33	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018147s033s038s039s040s042lbl.pdf
08/13/2010	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018147s032lbl.pdf
07/05/2007	SUPPL-30	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018147s030lbl.pdf
01/24/2006	SUPPL-29	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018147s029lbl.pdf