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FDA Drug Application 050662 by ABBVIE

Application Number050662
Application Type New Drug Application
Sponsor ApplicantABBVIE
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
AP010/31/1991N13724000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm 3/3/2006
AP06/17/1992SCS       
AP01/28/1993SCS       
AP02/28/1995SLR       
AP02/28/1995SE1       
AP06/8/1993SCM       
AP09/15/1993SCM       
AP012/23/1993SLR       
AP03/13/1995SCM       
AP04/18/1996SE1       
AP08/31/1995SCM       
AP08/26/1997SLR       
AP012/20/1996SLR3724013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050662s013_biaxin.pdf 8/2/1999
AP010/15/1996SCP       
AP01/16/1997SE1       
AP01/14/1997SCS       
AP04/29/1997SCS       
AP09/16/1997SLR       
AP09/16/1997SE1       
AP09/16/1998SE1       
AP01/5/1998SCP       
AP07/21/1998SLR       
AP04/27/1998SCF       
AP011/10/1998SLR       
AP010/22/1999SCF       
AP07/29/1999SLR       
AP05/4/1999SCS       
AP03/20/2000SLR9589028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-662S028_Biaxin.cfm 6/29/2004
AP010/20/2000SE14406029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-662S029_Biaxin.cfm 11/23/2001
AP010/20/2000SE11484029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50662S29ltr.pdf 10/20/2000
AP010/20/2000SE11485029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50662S29lbl.pdf 10/20/2000
AP06/6/2002SLR4407030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50662s030ltr.pdf 6/6/2002
AP06/6/2002SLR9591030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-662s030s031_Biaxin.cfm 6/29/2004
AP06/6/2002SLR9592031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50-662s030s031_Biaxin.cfm 6/29/2004
AP06/6/2002SLR4408031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50662s030ltr.pdf 6/6/2002
AP06/6/2002SCS       
AP011/8/2002SCS       
AP07/19/2004SLR9749036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50662s036,50697s003,50698s019,50775s007ltr.pdf 7/21/2004
AP010/4/2005SLR12846038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050662s038,050698s020,050775s008lbl.pdf 10/10/2005
AP010/4/2005SLR12912038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050662s038,050698s020,050775s008ltr.pdf 10/20/2005
AP07/5/2006SLR14457039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050662s039, 050698s021, 050775s009LTR.pdf 7/13/2006
AP012/18/2007SLR18683040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050662s040,050698s022,050775s011lbl.pdf 12/27/2007
AP012/18/2007SLR18817040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050662s040, 050698s022, 050775s011ltr.pdf 1/9/2008
AP05/21/2008SLR19895041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050662s041,050698s023,050775s012ltr.pdf 5/29/2008
AP08/14/2009SLR23441042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050662s042,050698s024,050775s013lbl.pdf 9/22/2009
AP08/14/2009SLR24061042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050662s042,050698s024,050775s013ltr.pdf 11/20/2009
AP05/27/2011SLR28998043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050662s043,s045,050698s025,s027,050775s014,s016ltr.pdf 5/31/2011
AP05/27/2011SLR29008043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s027,050775s014s016lbl.pdf 5/31/2011
AP05/3/2012SLR32633044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s030,050775s015s019lbl.pdf 5/7/2012
AP05/3/2012SLR32667044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s044,s050,050698s026,s030,050775s015,s019ltr.pdf 5/9/2012
AP05/27/2011SLR29009045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s027,050775s014s016lbl.pdf 5/31/2011
AP05/27/2011SLR28999045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050662s043,s045,050698s025,s027,050775s014,s016ltr.pdf 5/31/2011
AP06/1/2012SLR32809046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s046,050698s028,050775s017lltr.pdf 6/5/2012
AP07/5/2012SLR33101048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s048,050698s029,050775s018ltr.pdf 7/10/2012
AP07/5/2012SLR33110048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s048,050698s029,050775s018lbl.pdf 7/10/2012
AP011/23/2012SCM       
AP05/3/2012SLR32668050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s044,s050,050698s026,s030,050775s015,s019ltr.pdf 5/9/2012
AP05/3/2012SLR32634050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s030,050775s015s019lbl.pdf 5/7/2012
AP09/9/2013SLR37049052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,050698Orig1s031,s032,050775Orig1s020,s021ltr.pdf 9/11/2013
AP09/9/2013SLR37027052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050662s052lbl.pdf 9/9/2013
AP09/9/2013SLR37028053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050662s053lbl.pdf 9/9/2013
AP09/9/2013SLR37050053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,050698Orig1s031,s032,050775Orig1s020,s021ltr.pdf 9/11/2013
AP05/26/2016SLR46191054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050662Orig1s054,050698Orig1s033,050775Orig1s022ltr.pdf 5/31/2016
AP05/26/2016SLR46218054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050662s054,050698s033,050775s002lbl.pdf 6/1/2016
AP07/25/2014SLR40022055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050662Orig1s055,050698Orig1s035,050775Orig1s023ltr.pdf 7/28/2014
AP07/25/2014SLR40172055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050662Orig1s055,050698Orig1s035,050775Orig1s023lbl.pdf 8/7/2014
AP01/8/2015SLR41565056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050662Orig1s056,050698Orig1s036,050775Orig1s024ltr.pdf 1/9/2015
AP01/8/2015SLR41615056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s056lbl.pdf 1/12/2015
AP010/23/2015SLR44317057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050662Orig1s057,050698Orig1s037,050775Orig1s025ltr.pdf 10/28/2015
AP010/23/2015SLR44335057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s057,050698s037,050775s025lbl.pdf 10/29/2015




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