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FDA Drug Application 021192 by NOVARTIS

Application Number021192
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
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
AP010/6/2000N1418000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21192ltr.pdf 10/6/2000
AP010/6/2000N8027000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol.cfm 3/24/2004
AP010/6/2000N9158000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol_Prntlbl.pdf 6/8/2004
AP09/24/2001SCM       
AP09/25/2001SLR5555002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21192s2lbl.pdf 5/1/2003
AP02/11/2002SCM20413003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021192_s003_LESCOL_CAPSULES.pdf 8/1/2008
AP09/6/2002SLR2778004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20261slr032,21192slr004ltr.pdf 9/6/2002
AP09/6/2002SLR2779004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20261s32,21192s4lbl.pdf 9/6/2002
AP09/6/2002SLR20412004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021192_s004_LESCOL_CAPSULES.pdf 8/1/2008
AP05/27/2003SE15810005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20261se1-033,21192se1-005ltr.pdf 6/8/2003
AP05/27/2003SE15881005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20261se1-033,21192se1-005_lescol_lbl.pdf 6/8/2003
AP01/5/2005SLR10930008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20261s034,21192s008ltr.pdf 1/11/2005
AP01/5/2005SLR10941008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20261s034,21192s008lbl.pdf 1/11/2005
AP04/10/2006SE213897010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021192,s010,011,020261s035,s036lbl.pdf 4/12/2006
AP04/10/2006SE213904010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261s035, s036, 021192s010, s011ltr.pdf 4/13/2006
AP04/10/2006SE513898011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021192,s010,011,020261s035,s036lbl.pdf 4/12/2006
AP04/10/2006SE513905011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261s035, s036, 021192s010, s011ltr.pdf 4/13/2006
AP03/22/2006SLR13860012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261S037,021192S012ltr.pdf 4/5/2006
AP03/22/2006SLR13863012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020261S037,021192S012lbl.pdf 4/5/2006
AP06/12/2007SLR16770013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020261s039, 021192s013ltr.pdf 6/14/2007
AP06/12/2007SLR16775013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020261s039,021192s013lbl.pdf 6/14/2007
AP06/17/2011SLR29294016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020261s042,021192s016ltr.pdf 6/28/2011
AP06/17/2011SLR29309016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020261s042,021192s016lbl.pdf 6/28/2011
AP02/28/2012SLR31934019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021192s019lbl.pdf 2/28/2012
AP02/28/2012SLR31940019Tracked Changes Label  http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021192s019-trackedchangeslbl.pdf 2/28/2012
AP02/28/2012SLR31946019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020261s046,021192s019ltr.pdf 2/28/2012
AP02/28/2012SLR32301019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021192s019.pdf 3/30/2012
AP06/25/2013SCM       
AP010/31/2012SLR34252021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020261Orig1s048,021192s021ltr.pdf 11/5/2012
AP010/31/2012SLR34319021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020261s048,021192s021lbl.pdf 11/6/2012
AP011/5/2015SCM       




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