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FDA Drug Application 201739 by KALEO INC

Application Number201739
Application Type New Drug Application
Sponsor ApplicantKALEO INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA07/29/2011TA29819000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201739s000TALtr.pdf 8/18/2011
TA07/29/2011TA33433000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201739Orig1s000ltr.pdf 8/14/2012
TA07/29/2011TA33460000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201739s000lbl.pdf 8/15/2012
TA07/29/2011TA34521000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201739_auviQ_toc.cfm 12/4/2012
AP18/10/2012N29819000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201739s000TALtr.pdf 8/18/2011
AP18/10/2012N33433000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201739Orig1s000ltr.pdf 8/14/2012
AP18/10/2012N33460000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201739s000lbl.pdf 8/15/2012
AP18/10/2012N34521000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201739_auviQ_toc.cfm 12/4/2012
AP03/22/2014SCM       
AP04/22/2015SCM       
AP05/18/2016SLR46062004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201739Orig1s004ltr.pdf 5/19/2016
AP05/18/2016SLR46093004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201739s004lbl.pdf 5/20/2016




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