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FDA Drug Application 022560 by APIL

Application Number022560
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
AP010/8/2010N31083000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm 12/20/2011
AP010/8/2010N26667000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022560s000lbl.pdf 10/18/2010
AP010/8/2010N26670000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022560s000ltr.pdf 10/19/2010
AP010/8/2010N27647000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241450.pdf 2/1/2011
AP010/8/2010N28273000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022560Orig1s000TOC.cfm 3/21/2011
AP010/8/2010N28274000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022560Orig1s000SumR.pdf 3/21/2011
AP01/25/2011SLR27866001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022560s001,s002ltr.pdf 2/15/2011
AP01/25/2011SLR32167001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022560s001lbl.pdf 3/22/2012
AP01/25/2011SLR32168002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022560s001lbl.pdf 3/22/2012
AP01/25/2011SLR27865002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022560s001,s002ltr.pdf 2/15/2011
AP08/22/2011SLR29847003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022560s003ltr.pdf 8/24/2011
AP08/13/2012SLR33447004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022560Orig1s004ltr.pdf 8/15/2012
AP08/13/2012SLR33462004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022560s004lbl.pdf 8/15/2012
AP04/19/2013SLR35791005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022560s005lbl.pdf 4/23/2013
AP04/19/2013SLR35830005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022560Orig1s005ltr.pdf 4/24/2013
AP03/26/2015SLR42312006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022560Orig1s006ltr.pdf 3/27/2015
AP03/26/2015SLR42318006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022560s006lbl.pdf 3/27/2015
AP04/8/2015SLR42482007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022560s007lbl.pdf 4/10/2015
AP04/8/2015SLR42508007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022560Orig1s007ltr.pdf 4/13/2015




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