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FDA Drug Application 204824 by ANTARES PHARMA INC

Application Number204824
Application Type New Drug Application
Sponsor ApplicantANTARES PHARMA 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
AP010/11/2013N37430000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204824Orig1s000,204824Orig2s000_replace_ltr.pdf 10/16/2013
AP110/11/2013N37430000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204824Orig1s000,204824Orig2s000_replace_ltr.pdf 10/16/2013
AP010/11/2013N37436000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204824Orig1s000, 204824Orig2s000lbledt.pdf 10/17/2013
AP110/11/2013N37436000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204824Orig1s000, 204824Orig2s000lbledt.pdf 10/17/2013
AP010/11/2013N38432000Orig1  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204824Orig1s000TOC.cfm 2/3/2014
AP110/11/2013N38432000Orig1  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204824Orig1s000TOC.cfm 2/3/2014
AP010/11/2013N38433000Orig2  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204824Orig2s000TOC.cfm 2/3/2014
AP110/11/2013N38433000Orig2  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204824Orig2s000TOC.cfm 2/3/2014
AP010/11/2013N38451000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204824Orig2s000TOC.cfm 2/4/2014
AP110/11/2013N38451000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204824Orig2s000TOC.cfm 2/4/2014
AP010/7/2014SCM       
AP010/8/2014SCM       
AP011/7/2014SCM40975003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204824s003lbl.pdf 11/10/2014
AP011/7/2014SCM40977003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204824Orig1s003ltr.pdf 11/12/2014
AP03/24/2016SCM46182004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204824s004lbl.pdf 5/27/2016




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