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FDA Drug Application 021513 by APIL

Application Number021513
Application Type New Drug Application
Sponsor ApplicantAPIL
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
AP012/22/2004N10806000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021513ltr.pdf 12/29/2004
AP012/22/2004N10829000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021513lbl.pdf 12/29/2004
AP012/22/2004N11096000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-513_Enablex.cfm 2/8/2005
AP010/20/2005SCM12958002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021513s002lbl.pdf 10/25/2005
AP010/20/2005SCM12961002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021513s002ltr.pdf 10/25/2005
AP04/18/2008SLR19688004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021513s004ltr.pdf 4/22/2008
AP04/18/2008SLR19934004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021513s004lbl.pdf 6/5/2008
AP012/12/2008SLR21371005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021513s005ltrCorrectedCopy.pdf 12/19/2008
AP012/12/2008SLR21479005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021513s005lbl.pdf 1/2/2009
AP010/19/2010SLR26694006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021513s006lbl.pdf 10/19/2010
AP010/19/2010SLR26730006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021513s006ltr.pdf 10/25/2010
AP04/18/2011SLR28583007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021513s007lbl.pdf 4/18/2011
AP04/18/2011SLR28586007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021513s007ltr.pdf 4/20/2011
AP01/13/2012SLR31402008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021513s008ltr.pdf 1/18/2012
AP01/13/2012SLR31527008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021513s008lbl.pdf 1/26/2012
AP012/5/2013SCM       
AP03/15/2012SLR32136010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021513s010lbl.pdf 3/16/2012
AP03/15/2012SLR32149010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021513Orig1s010ltr.pdf 3/19/2012
AP04/3/2013SCM       
AP08/9/2013SCM       
AP09/20/2013SCM       
AP012/18/2015SCM       
AP01/13/2016SCM       




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