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FDA Drug Application 007961 by APTALIS PHARMA US

Application Number007961
Application Type New Drug Application
Sponsor ApplicantAPTALIS PHARMA US
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
AP04/30/1951N       
AP08/4/1989SPD       
AP010/15/1984SLR       
AP010/15/1984SCS       
AP05/13/1985SLR       
AP06/12/1985SCS       
AP02/6/1987SLR       
AP01/4/1993SCM       
AP09/25/1990SLR       
AP09/9/1996SLR       
AP08/17/1999SLR       
AP02/2/2007SLR15797026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/007409s040, 007961s026, 008370s031LTR.pdf 2/12/2007
AP02/2/2007SLR15850026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/007409s040,007961s026,008370s031lbl.pdf 2/21/2007
AP08/1/2011SLR29643028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007961s028lbl.pdf 8/1/2011
AP08/1/2011SLR29649028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/007409s041,007961s028,008370s032ltr.pdf 8/2/2011




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