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FDA Drug Application 204412 by APIL

Application Number204412
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
AP02/1/2013N35074000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204412Orig1s000ltr.pdf 2/5/2013
AP02/1/2013N35076000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204412s000lbl.pdf 2/5/2013
AP02/1/2013N36249000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204412_delzicol_toc.cfm 6/10/2013
AP07/9/2013SCM       
AP010/22/2013SCM       
AP04/28/2014SE839162003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204412Orig1s003ltr.pdf 4/29/2014
AP04/28/2014SE839168003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204412s003lbl.pdf 4/29/2014
AP010/27/2014SLR40890004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204412Orig1s004ltr.pdf 10/28/2014
AP010/27/2014SLR40894004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204412s004lbl.pdf 10/29/2014
AP012/2/2014SCM       
AP09/9/2015SE843841006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204412Orig1s006ltr.pdf 9/10/2015
AP09/9/2015SE843947006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204412s006lbl.pdf 9/22/2015




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