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FDA Drug Application 021524 by PROF DSPLS

Application Number021524
Application Type New Drug Application
Sponsor ApplicantPROF DSPLS
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
AP06/3/2005N17301000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021524s000TOC.cfm 7/18/2007
AP06/3/2005N11752000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021524ltr.pdf 6/7/2005
AP06/3/2005N11766000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021524lbl.pdf 6/7/2005
AP03/20/2007SCP16083003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021524s003ltr.pdf 3/23/2007
AP03/20/2007SCP16087003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021524s003lbl.pdf 3/23/2007
AP010/15/2007SCP18262004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021524s004lbl.pdf 10/22/2007
AP010/15/2007SCP18281004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021524s004ltr.pdf 10/22/2007
AP03/1/2012SLR32027010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021524s010ltr.pdf 3/5/2012
AP05/17/2012SLR32714011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021524Orig1s011ltr.pdf 5/18/2012
AP03/24/2014SLR38909014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021524Orig1s014ltr.pdf 3/26/2014
AP03/24/2014SLR38914014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021524Orig1s014lbl.pdf 3/26/2014
AP07/25/2014SLR40018015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021524Orig1s015ltr.pdf 7/28/2014
AP07/25/2014SLR40048015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021524Orig1s015lbl.pdf 7/29/2014




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