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FDA Drug Application 012806 by AQUA PHARMS

Application Number012806
Application Type New Drug Application
Sponsor ApplicantAQUA PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/18/1965N       
AP011/11/1977SCS       
AP02/23/1977SLR       
AP012/14/1977SCE       
AP07/24/1978SLR       
AP06/30/1978SLR       
AP011/26/1979SCS       
AP08/12/1980SLR       
AP010/8/1982SPD       
AP011/14/1986SLR       
AP06/3/1987SCM       
AP012/18/1987SCS       
AP010/2/1990SCP       
AP08/30/1991SCP       
AP011/6/1998SCM       
AP07/17/2002SCM2580028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12806scm028ltr.pdf 7/17/2002
AP012/14/2012SCM       
AP06/12/2013SCM36291036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012806Orig1s036ltr.pdf 6/14/2013
AP07/23/2013SCM36663037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012806s037lbl.pdf 7/30/2013




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