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FDA Drug Application 021519 by ANI PHARMS

Application Number021519
Application Type New Drug Application
Sponsor ApplicantANI PHARMS
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
AP012/20/2007N18673000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021519lbl.pdf 12/27/2007
AP012/20/2007N18812000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021519s000ltr.pdf 1/9/2008
AP012/20/2007N21204000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021519_luvox_toc.cfm 11/10/2008
AP012/20/2007N21205000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021519s000_SumR.pdf 11/10/2008
AP012/20/2007N28422000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM249169.pdf 4/1/2011
AP012/20/2007N31750000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113425.htm 2/13/2012
AP02/24/2009SLR21920001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021519s001,022033s002ltr.pdf 2/27/2009
AP02/24/2009SLR22019001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021519s001lbl.pdf 3/17/2009
AP03/16/2011SLR28271002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021519s002ltr.pdf 3/21/2011
AP03/16/2011SLR28299002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021519s002lbl.pdf 3/21/2011
AP011/30/2012SLR34515003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021519s003lbl.pdf 12/3/2012
AP011/30/2012SLR34516003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021519Orig1s003ltr.pdf 12/3/2012
AP05/24/2013SCM       
AP05/28/2013SCM       
AP07/10/2013SCM       
AP010/23/2014SCM       
AP07/18/2014SLR39945008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021519Orig1s008ltr.pdf 7/23/2014
AP07/18/2014SLR40051008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021519Orig1s008lbl.pdf 7/29/2014




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