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FDA Drug Application 018029 by NOVARTIS

Application Number018029
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/30/1982N16557000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm 5/10/2007
AP03/30/1982N24072000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089095.pdf 11/20/2009
AP010/31/1988SCS       
AP09/14/1983SCS       
AP03/13/1985SCE       
AP01/21/1986SLR       
AP010/7/1986SCS       
AP04/20/1987SCS       
AP07/21/1988SCS       
AP07/9/1997SLR       
AP03/9/1990SCM       
AP03/9/1994SCS       
AP07/9/1997SLR       
AP04/15/1994SCS       
AP06/18/1993SCS       
AP05/31/1994SCS       
AP08/19/1994SCM       
AP07/9/1997SLR       
AP012/15/1995SLR       
AP07/9/1997SLR       
AP02/20/1998SLR       
AP04/24/1998SCS       
AP08/12/1998SCS       
AP09/17/1998SCM       
AP011/24/1998SCM       
AP04/15/1999SCP       
AP05/21/2004SLR8681028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10187slr057,058,18029slr028,029ltr.pdf 5/27/2004
AP05/21/2004N8682029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10187slr057,058,18029slr028,029ltr.pdf 5/27/2004
AP03/13/2001SCS       
AP08/15/2001SCS       
AP01/11/2002SLR3219032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10187s60ltr.pdf 1/11/2002
AP05/29/2002SCM       
AP06/12/2002SCS       
AP08/8/2006SLR14646037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf 8/9/2006
AP08/8/2006SLR14677037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010187s066,067,018029s037,s038,021284s006,s008LTR.pdf 8/11/2006
AP08/8/2006SLR14678038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/010187s066,067,018029s037,s038,021284s006,s008LTR.pdf 8/11/2006
AP08/8/2006SLR14647038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf 8/9/2006
AP04/25/2007SLR16353040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010187s069,018029s040,021284s011lbl.pdf 5/1/2007
AP04/25/2007SLR16395040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/010187s069,018029s040,021284s011ltr.pdf 5/1/2007
AP011/15/2010SLR26973042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010187s072,018029s042lbl.pdf 11/17/2010
AP011/15/2010SLR26983042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010187s072,018029s042,021284s017ltr.pdf 11/18/2010
AP012/9/2010SLR27272043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018029s043lbl.pdf 12/10/2010
AP012/9/2010SLR27290043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021278s013,010187s073,021284s018,018029s043ltr.pdf 12/15/2010
AP06/7/2013SLR36254044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010187Orig1s074,018029Orig1s044,021284Orig1s019ltr.pdf 6/11/2013
AP06/7/2013SLR36260044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s074,018029s044lbl.pdf 6/11/2013
AP010/25/2013SCM       
AP012/13/2013SLR38049047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/010187Orig1s077,018029Orig1s047,021284Orig1s023ltr.pdf 12/16/2013
AP012/13/2013SLR38059047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/010187s077lbl.pdf 12/17/2013
AP04/17/2015SLR42589049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/010187Orig1s080,018029Orig1s049,021284Orig1s027ltr.pdf 4/21/2015
AP04/17/2015SLR42604049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010187s080,018029s049,021284s027lbl.pdf 4/21/2015
AP012/1/2015SCM       




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