Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018972
Company: WYETH PHARMS

• Medication Guide

• Other Important Information from FDA

Products on NDA 18972

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CORDARONE	AMIODARONE HYDROCHLORIDE	200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Labels for NDA 018972

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/17/2018	SUPPL-54	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018972s054lbl.pdf
04/07/2017	SUPPL-53	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018972s053lbl.pdf
11/22/2016	SUPPL-52	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018972s052lbl.pdf
04/22/2016	SUPPL-51	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018972s051lbl.pdf
03/27/2015	SUPPL-47	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018972s047lbl.pdf
12/22/2014	SUPPL-50	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018972s050lbl.pdf
01/22/2014	SUPPL-48	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018972s048lbl.pdf
11/14/2011	SUPPL-44	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018972s044lbl.pdf
12/13/2010	SUPPL-42	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018972s042lbl.pdf
11/19/2009	SUPPL-41	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s041lbl.pdf
04/21/2009	SUPPL-39	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s038s039lbl.pdf
04/21/2009	SUPPL-38	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s038s039lbl.pdf
12/03/2004	SUPPL-30	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18972s030lbl.pdf