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FDA Drug Application 021830 by APIL

Application Number021830
Application Type New Drug Application
Sponsor ApplicantAPIL
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
AP05/29/2008N19923000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021830s000ltr.pdf 6/3/2008
AP05/29/2008N19989000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021830lbl.pdf 6/12/2008
AP05/29/2008N20245000   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021830s000_SUMR.pdf 7/17/2008
AP05/29/2008N22585000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021830TOC.cfm 5/15/2009
AP04/23/2009SLR22326002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021830s002ltr.pdf 4/27/2009
AP04/23/2009SLR22339002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021830s002lbl.pdf 4/28/2009
AP05/24/2010SLR25634005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021830s005ltr.pdf 5/28/2010
AP05/24/2010SLR32685005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021830s005lbl.pdf 5/14/2012
AP010/18/2013S37482006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021830Orig1s006ltr.pdf 10/21/2013
AP010/18/2013S37516006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021830s006lbl.pdf 10/22/2013
AP01/13/2014SCM       
AP010/22/2015SCM       
AP05/5/2016SLR45882010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021830Orig1s010ltr.pdf 5/6/2016
AP05/5/2016SLR45883010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021830Orig1s010lbl.pdf 5/6/2016




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