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FDA Drug Application 050641 by AQUA PHARMS

Application Number050641
Application Type New Drug Application
Sponsor ApplicantAQUA PHARMS
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
AP012/29/1989N       
AP011/15/1991SLR       
AP09/25/1991SCP       
AP02/10/1992SCS       
AP011/15/1991SLR       
AP03/6/1992SLR       
AP06/24/1992SCP       
AP01/7/1994SCE       
AP03/21/2002SLR3633008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50641s8ltr.pdf 3/21/2002
AP06/18/2002SLR3632010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50641s010ltr.pdf 6/18/2002
AP01/31/2007SCS15795013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050641s013ltr.pdf 2/12/2007
AP012/20/2007SLR18715014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050641s014lbl.pdf 1/8/2008
AP012/20/2007SLR18774014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050641s014ltr.pdf 1/9/2008
AP01/11/2012SLR31392018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050641s018ltr.pdf 1/17/2012
AP01/11/2012SLR31477018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050641s018lbl.pdf 1/23/2012
AP03/8/2011SLR28210026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050641s026ltr.pdf 3/10/2011
AP03/8/2011SLR28233026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050641s026lbl.pdf 3/11/2011
AP010/11/2013SLR37420027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050641Orig1s027ltr.pdf 10/15/2013
AP010/11/2013SLR37438027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050641s027lbl.pdf 10/17/2013
AP08/5/2016SCM       




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