Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018972
Company: WYETH PHARMS
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CORDARONE AMIODARONE HYDROCHLORIDE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
12/24/1985 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/18-972_Cardarone.cfm
Supplements
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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018972s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018972Orig1s054ltr.pdf
04/07/2017 SUPPL-53 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018972s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018972Orig1s053ltr.pdf
11/22/2016 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018972s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018972Orig1s052ltr.pdf
04/22/2016 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018972s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018972Orig1s051ltr.pdf
12/22/2014 SUPPL-50 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018972s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018972Orig1s050ltr.pdf
01/17/2014 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

01/22/2014 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018972s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018972Orig1s048ltr.pdf
03/27/2015 SUPPL-47 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018972s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018972Orig1s047ltr.pdf
11/20/2012 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

11/14/2011 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018972s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018972s044ltr.pdf
12/13/2010 SUPPL-42 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018972s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018972s042ltr.pdf
11/19/2009 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018972s041ltr.pdf
09/28/2009 SUPPL-40 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018972s040ltr.pdf
04/21/2009 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s038s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018972s038,s39ltr.pdf
04/21/2009 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s038s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018972s038,s039ltr.pdf
10/17/2008 SUPPL-37 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018972s037ltr.pdf
11/13/2007 SUPPL-36 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018972s036LTR.pdf
10/02/2007 SUPPL-35 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018972s035ltr.pdf
03/30/2007 SUPPL-34 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018972s034ltr.pdf
08/28/2006 SUPPL-33 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018972s033ltr.pdf
09/21/2006 SUPPL-32 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018972s032ltr.pdf
08/23/2005 SUPPL-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018972s031ltr.pdf
12/03/2004 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18972s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972s030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018972s030_Cordarone.cfm
11/01/2004 SUPPL-29 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972s029ltr.pdf
09/02/2004 SUPPL-28 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972s028ltr.pdf
05/21/2004 SUPPL-27 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972slr022,027ltr.pdf
05/06/2003 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/018972s026ltr.pdf
12/18/2002 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18972slr025ltr.pdf
09/20/2002 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/2003 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/r_18972slr023ltr.pdf
05/21/2004 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972slr022,027ltr.pdf
12/18/2001 SUPPL-21 Labeling

Label is not available on this site.

10/08/1999 SUPPL-20 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972-s019_cordarone.pdf
10/08/1999 SUPPL-19 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972-s019_cordarone.pdf
06/15/1998 SUPPL-18 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18972-S014_Cordarone.pdf
01/05/1999 SUPPL-17 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972s015s017_appltrs.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972S015S017.cfm
06/15/1998 SUPPL-16 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18972-S014_Cordarone.pdf
01/05/1999 SUPPL-15 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972s015s017_appltrs.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972S015S017.cfm
10/18/1995 SUPPL-14 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18972-S014_Cordarone.pdf
04/14/1994 SUPPL-12 Labeling

Label is not available on this site.

08/09/1990 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/09/1990 SUPPL-10 Labeling

Label is not available on this site.

02/10/1989 SUPPL-9 Labeling

Label is not available on this site.

07/28/1989 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/29/1988 SUPPL-7 Labeling

Label is not available on this site.

10/28/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/07/1987 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/14/1988 SUPPL-4 Labeling

Label is not available on this site.

05/15/1987 SUPPL-3 Labeling

Label is not available on this site.

12/13/1988 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/07/1986 SUPPL-1 Labeling

Label is not available on this site.

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

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