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FDA Drug Application 021978 by AQUA PHARMS

Application Number021978
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
AP09/19/2006N14899000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021978s000ltr.pdf 9/20/2006
AP09/19/2006N14916000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021978lbl.pdf 9/20/2006
AP09/19/2006N20747000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021978_verdeso_toc.cfm 9/5/2008
AP09/19/2006N20748000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021978s000_SumR.pdf 9/5/2008
AP04/22/2010SLR25350007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021978s007ltr.pdf 4/28/2010
AP04/22/2010SLR25423007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021978s007lbl.pdf 5/3/2010
AP08/22/2011SLR29861009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021978s009lbl.pdf 8/22/2011
AP08/22/2011SLR29877009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021978s009ltr.pdf 8/26/2011
AP04/2/2013SLR35627010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021978Orig1s010ltr.pdf 4/3/2013
AP04/2/2013SLR35654010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021978s010lbl.pdf 4/9/2013
AP08/20/2015SCM       




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