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FDA Drug Application 020261 by NOVARTIS

Application Number020261
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/31/1993N       
AP03/13/1995SCS       
AP03/21/1994SLR23335002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020261_s002_Lescol Capsules.pdf 9/16/2009
AP011/28/1994SCP16994003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020261_S003_LESCOL_AP.pdf 7/6/2007
AP011/10/1994SCS16993004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020261_S004_LESCOL_AP.pdf 7/6/2007
AP05/3/1995SLR       
AP03/20/1996SE2       
AP010/17/1995SCS19192007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020261_S007_LESCOL_CAPSULES.pdf 2/19/2008
AP012/22/1995SCM       
AP02/8/1996SCS19191009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020261_S009_LESCOL_CAPSULES.pdf 2/19/2008
AP04/30/1996SCM17888010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020261_S010_LESCOL.pdf 9/14/2007
AP010/8/1998SCS19587011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020261_S011_LESCOL_CAPSULES.pdf 4/2/2008
AP010/1/1997SE1       
AP06/16/1997SCS18113013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020261_S013_LESCOL.pdf 9/26/2007
AP04/21/1997SCP18112014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020261_S014_LESCOL.pdf 9/26/2007
AP011/20/1997SCP19214015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020261_S016_LESCOL_TABLETS.pdf 2/19/2008
AP04/23/1998SCS19213016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020261_S016_LESCOL_TABLETS.pdf 2/19/2008
AP08/5/1998SCM19212017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020261_S017_LESCOL_TABLETS.pdf 2/19/2008
AP03/8/1999SE1977018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261s018s022.cfm 5/8/1999
AP03/8/1999SE14785018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261s018s022_appltr_medr_chemr.pdf 3/8/1999
AP01/4/1999SLR19586019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261_S019_LESCOL_CAPSULES.pdf 4/2/2008
AP04/21/1999SCP19196020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261_S020_LESCOL_CAPSULES.pdf 2/19/2008
AP05/14/1999SCS19195021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261_S021_LESCOL_CAPSULES.pdf 2/19/2008
AP03/8/1999SE84786022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261s018s022_appltr_medr_chemr.pdf 3/8/1999
AP03/8/1999SE81240022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020261s018s022.cfm 3/8/1999
AP010/14/1999SCM       
AP010/23/2000SE81503024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20261S24ltr.pdf 10/23/2000
AP010/23/2000SE81504024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20261S24lbl.pdf 10/23/2000
AP012/18/2000SE11518025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20261S25ltr.pdf 12/18/2000
AP07/26/2000SCM       
AP010/6/2000SLR9159028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol.cfm 6/8/2004
AP010/6/2000SLR9160028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol_Approv.pdf 6/8/2004
AP010/6/2000SLR9161028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-192_Lescol_Prntlbl.pdf 6/8/2004
AP05/23/2001SCM20469029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020261_s029_LESCOL_CAPSULES.pdf 8/4/2008
AP09/25/2001SLR5405030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20261s30lbl.pdf 4/22/2003
AP02/11/2002SCM20444031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020261_s031_LESCOL_CAPSULES.pdf 8/4/2008
AP09/6/2002SLR2776032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20261s32,21192s4lbl.pdf 9/6/2002
AP09/6/2002SLR2777032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20261slr032,21192slr004ltr.pdf 9/6/2002
AP09/6/2002SLR20443032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020261_s032_LESCOL_CAPSULES.pdf 8/4/2008
AP05/27/2003SE116195033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020261_S033_LESCOL_CAPS_AP.pdf 4/9/2007
AP05/27/2003SE15809033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20261se1-033,21192se1-005ltr.pdf 6/8/2003
AP05/27/2003SE15880033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20261se1-033,21192se1-005_lescol_lbl.pdf 6/8/2003
AP01/5/2005SLR10929034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20261s034,21192s008ltr.pdf 1/11/2005
AP01/5/2005SLR10940034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20261s034,21192s008lbl.pdf 1/11/2005
AP01/5/2005SLR23336034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020261_s034_Lescol Capsules.pdf 9/16/2009
AP04/10/2006SE213895035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021192,s010,011,020261s035,s036lbl.pdf 4/12/2006
AP04/10/2006SE213906035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261s035, s036, 021192s010, s011ltr.pdf 4/13/2006
AP04/10/2006SE513907036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261s035, s036, 021192s010, s011ltr.pdf 4/13/2006
AP04/10/2006SE513896036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021192,s010,011,020261s035,s036lbl.pdf 4/12/2006
AP03/22/2006SLR13861037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020261S037,021192S012ltr.pdf 4/5/2006
AP03/22/2006SLR13864037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020261S037,021192S012lbl.pdf 4/5/2006
AP06/12/2007SLR16771039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020261s039, 021192s013ltr.pdf 6/14/2007
AP06/12/2007SLR16776039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020261s039,021192s013lbl.pdf 6/14/2007
AP06/17/2011SLR29293042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020261s042,021192s016ltr.pdf 6/28/2011
AP06/17/2011SLR29310042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020261s042,021192s016lbl.pdf 6/28/2011
AP02/28/2012SLR31935046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020261s046lbl.pdf 2/28/2012
AP02/28/2012SLR31938046Tracked Changes Label  http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020261S046-trackedchangeslbl.pdf 2/28/2012
AP02/28/2012SLR31945046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020261s046,021192s019ltr.pdf 2/28/2012
AP02/28/2012SLR32303046   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020261s046.pdf 3/30/2012
AP06/25/2013SCM       
AP010/31/2012SLR34251048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020261Orig1s048,021192s021ltr.pdf 11/5/2012
AP010/31/2012SLR34318048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020261s048,021192s021lbl.pdf 11/6/2012
AP06/17/2015SCM       
AP011/5/2015SCM       
AP09/19/2016SCM       




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