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FDA Drug Application 050775 by ABBVIE

Application Number050775
Application Type New Drug Application
Sponsor ApplicantABBVIE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/3/2000N1266000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50775ltr.pdf 3/3/2000
AP03/3/2000N1267000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50775lbl.pdf 3/3/2000
AP03/3/2000N4412000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50755_BiaxinXL.cfm 10/11/2001
AP03/3/2000N13726000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm 3/3/2006
AP08/2/2001SE14409001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50775s1ltr.pdf 8/3/2001
AP08/2/2001SE14410001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50775s1lbl.pdf 8/3/2001
AP08/2/2001SE14411001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50775S1_Biaxin.cfm 11/23/2001
AP03/15/2002SLR       
AP011/16/2001SCP       
AP04/11/2003SLR5391004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50775slr004ltr.pdf 4/18/2003
AP04/11/2003SLR9599004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/50-775s004_BiaxinXL.cfm 6/29/2004
AP012/20/2002SCS       
AP07/19/2004SLR9752007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50662s036,50697s003,50698s019,50775s007ltr.pdf 7/21/2004
AP010/4/2005SLR12844008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050662s038,050698s020,050775s008lbl.pdf 10/10/2005
AP010/4/2005SLR12914008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050662s038,050698s020,050775s008ltr.pdf 10/20/2005
AP07/5/2006SLR14455009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050662s039, 050698s021, 050775s009LTR.pdf 7/13/2006
AP012/18/2007SLR18681011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050662s040,050698s022,050775s011lbl.pdf 12/27/2007
AP012/18/2007SLR18819011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050662s040, 050698s022, 050775s011ltr.pdf 1/9/2008
AP05/21/2008SLR19897012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050662s041,050698s023,050775s012ltr.pdf 5/29/2008
AP08/14/2009SLR23443013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050662s042,050698s024,050775s013lbl.pdf 9/22/2009
AP08/14/2009SLR24064013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050662s042,050698s024,050775s013ltr.pdf 11/20/2009
AP05/27/2011SLR29002014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050662s043,s045,050698s025,s027,050775s014,s016ltr.pdf 5/31/2011
AP05/27/2011SLR29004014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s027,050775s014s016lbl.pdf 5/31/2011
AP05/3/2012SLR32629015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s030,050775s015s019lbl.pdf 5/7/2012
AP05/3/2012SLR32671015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s044,s050,050698s026,s030,050775s015,s019ltr.pdf 5/9/2012
AP05/27/2011SLR29005016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s027,050775s014s016lbl.pdf 5/31/2011
AP05/27/2011SLR29003016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050662s043,s045,050698s025,s027,050775s014,s016ltr.pdf 5/31/2011
AP06/1/2012SLR32811017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s046,050698s028,050775s017lltr.pdf 6/5/2012
AP07/5/2012SLR33104018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s048,050698s029,050775s018ltr.pdf 7/10/2012
AP07/5/2012SLR33108018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s048,050698s029,050775s018lbl.pdf 7/10/2012
AP05/3/2012SLR32630019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s030,050775s015s019lbl.pdf 5/7/2012
AP05/3/2012SLR32672019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s044,s050,050698s026,s030,050775s015,s019ltr.pdf 5/9/2012
AP09/9/2013SLR37031020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050775s020lbl.pdf 9/9/2013
AP09/9/2013SLR37053020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,050698Orig1s031,s032,050775Orig1s020,s021ltr.pdf 9/11/2013
AP09/9/2013SLR37054021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,050698Orig1s031,s032,050775Orig1s020,s021ltr.pdf 9/11/2013
AP09/9/2013SLR37192021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050775s020lbl.pdf 9/24/2013
AP05/26/2016SLR46193022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050662Orig1s054,050698Orig1s033,050775Orig1s022ltr.pdf 5/31/2016
AP05/26/2016SLR46220022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050662s054,050698s033,050775s002lbl.pdf 6/1/2016
AP07/25/2014SLR40024023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050662Orig1s055,050698Orig1s035,050775Orig1s023ltr.pdf 7/28/2014
AP07/25/2014SLR40174023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050662Orig1s055,050698Orig1s035,050775Orig1s023lbl.pdf 8/7/2014
AP01/8/2015SLR41567024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050662Orig1s056,050698Orig1s036,050775Orig1s024ltr.pdf 1/9/2015
AP01/8/2015SLR41617024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s056lbl.pdf 1/12/2015
AP010/23/2015SLR44319025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050662Orig1s057,050698Orig1s037,050775Orig1s025ltr.pdf 10/28/2015
AP010/23/2015SLR44333025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s057,050698s037,050775s025lbl.pdf 10/29/2015
AP012/4/2008SLR       




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