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FDA Drug Application 018972 by WYETH PHARMS INC

Application Number018972
Application Type New Drug Application
Sponsor ApplicantWYETH PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/24/1985N10085000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/18-972_Cardarone.cfm 8/26/2004
AP012/24/1985N12362000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm 7/29/2005
AP012/24/1985N23918000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM152841.pdf 11/16/2009
AP010/7/1986SLR       
AP012/13/1988SCP       
AP05/15/1987SLR       
AP09/14/1988SLR       
AP08/7/1987SCP       
AP010/28/1987SCM       
AP06/29/1988SLR       
AP07/28/1989SCF       
AP02/10/1989SLR       
AP08/9/1990SLR       
AP08/9/1990SCM       
AP04/14/1994SLR       
AP010/18/1995SLR2575014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18972-S014_Cordarone.pdf 6/15/1998
AP01/5/1999SLR132015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972S015S017.cfm 1/5/1999
AP01/5/1999SLR4632015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972s015s017_appltrs.pdf 1/5/1999
AP06/15/1998SLR2576016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18972-S014_Cordarone.pdf 6/15/1998
AP01/5/1999SLR4633017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972s015s017_appltrs.pdf 1/5/1999
AP01/5/1999SLR438017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972S015S017.cfm 1/5/1999
AP06/15/1998SLR2578018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/18972-S014_Cordarone.pdf 6/15/1998
AP010/8/1999SLR2569019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972-s019_cordarone.pdf 10/8/1999
AP010/8/1999SLR2572020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18972-s019_cordarone.pdf 10/8/1999
AP012/18/2001SLR       
AP05/21/2004SLR8669022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972slr022,027ltr.pdf 5/27/2004
AP04/30/2003SLR5741023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/r_18972slr023ltr.pdf 5/29/2003
AP09/20/2002SCS       
AP012/18/2002SLR8847025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18972slr025ltr.pdf 6/1/2004
AP05/6/2003SLR5764026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/018972s026ltr.pdf 5/30/2003
AP05/21/2004SLR8670027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972slr022,027ltr.pdf 5/27/2004
AP09/2/2004SLR10129028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972s028ltr.pdf 9/3/2004
AP011/1/2004SLR10538029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972s029ltr.pdf 11/8/2004
AP012/3/2004SLR10727030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18972s030lbl.pdf 12/6/2004
AP012/3/2004SLR10733030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972s030ltr.pdf 12/6/2004
AP012/3/2004SLR11457030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018972s030_Cordarone.cfm 4/27/2005
AP08/23/2005SLR12676031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018972s031ltr.pdf 8/31/2005
AP09/21/2006SLR14947032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018972s032ltr.pdf 9/25/2006
AP08/28/2006SLR14875033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018972s033ltr.pdf 9/18/2006
AP03/30/2007SLR16176034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018972s034ltr.pdf 4/9/2007
AP010/2/2007SLR18121035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018972s035ltr.pdf 10/4/2007
AP011/13/2007SLR18451036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018972s036LTR.pdf 11/19/2007
AP010/17/2008SLR21032037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018972s037ltr.pdf 10/21/2008
AP04/21/2009SLR22321038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018972s038,s039ltr.pdf 4/24/2009
AP04/21/2009SLR22332038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s038s039lbl.pdf 4/28/2009
AP04/21/2009SLR22333039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s038s039lbl.pdf 4/28/2009
AP04/21/2009SLR22322039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018972s038,s39ltr.pdf 4/24/2009
AP09/28/2009SLR23843040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018972s040ltr.pdf 11/12/2009
AP011/19/2009SLR24106041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018972s041lbl.pdf 11/23/2009
AP011/19/2009SLR24459041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018972s041ltr.pdf 1/7/2010
AP012/13/2010SLR27281042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018972s042lbl.pdf 12/13/2010
AP012/13/2010SLR27283042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018972s042ltr.pdf 12/15/2010
AP011/14/2011SLR30572044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018972s044lbl.pdf 11/14/2011
AP011/14/2011SLR30601044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018972s044ltr.pdf 11/16/2011
AP011/20/2012SCM       
AP03/27/2015SLR42322047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018972Orig1s047ltr.pdf 3/31/2015
AP03/27/2015SLR42366047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018972s047lbl.pdf 4/1/2015
AP01/22/2014SLR38351048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018972Orig1s048ltr.pdf 1/23/2014
AP01/22/2014SLR38358048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018972s048lbl.pdf 1/23/2014
AP01/17/2014SCM       
AP012/22/2014SLR41406050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018972Orig1s050ltr.pdf 12/24/2014
AP012/22/2014SLR41540050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018972s050lbl.pdf 1/8/2015
AP04/22/2016SLR45749051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018972Orig1s051ltr.pdf 4/26/2016
AP04/22/2016SLR45802051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018972s051lbl.pdf 4/29/2016




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