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FDA Drug Application 021860 by APIL

Application Number021860
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
AP05/19/2006N14151000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021860lbl.pdf 5/22/2006
AP05/19/2006N14153000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021860s000LTR.pdf 5/22/2006
AP05/19/2006N16534000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP05/19/2006N20745000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021860_sarafem_toc.cfm 9/5/2008
AP05/19/2006N27143000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089119.pdf 12/3/2010
AP04/5/2007SLR16167001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021860s001ltr.pdf 4/9/2007
AP04/5/2007SLR16184001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021860s001lbl.pdf 4/9/2007
AP011/30/2007SLR18597002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021860s002ltr.pdf 12/3/2007
AP011/30/2007SLR18607002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021860s002lbl.pdf 12/3/2007
AP04/22/2009SLR22324005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021860s005ltr.pdf 4/27/2009
AP04/22/2009SLR22338005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021860s005lbl.pdf 4/28/2009
AP07/5/2013SLR36499006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021860Orig1s006,s007,s008,s009ltr.pdf 7/8/2013
AP07/5/2013SLR36506006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021860s006s007s008s009lbl.pdf 7/8/2013
AP07/5/2013SLR36507007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021860s006s007s008s009lbl.pdf 7/8/2013
AP07/5/2013SLR36500007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021860Orig1s006,s007,s008,s009ltr.pdf 7/8/2013
AP07/5/2013SLR36501008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021860Orig1s006,s007,s008,s009ltr.pdf 7/8/2013
AP07/5/2013SLR36508008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021860s006s007s008s009lbl.pdf 7/8/2013
AP07/5/2013SLR36509009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021860s006s007s008s009lbl.pdf 7/8/2013
AP07/5/2013SLR36502009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021860Orig1s006,s007,s008,s009ltr.pdf 7/8/2013
AP012/1/2014SLR41125010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021860Orig1s010ltr.pdf 12/2/2014
AP012/1/2014SLR41137010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021860s010lbl.pdf 12/3/2014




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