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FDA Drug Application 050824 by GASTROENTERO

Application Number050824
Application Type New Drug Application
Sponsor ApplicantGASTROENTERO
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
AP02/8/2011N27803000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050824s000lbl.pdf 2/9/2011
AP02/8/2011N27830000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050824s000ltr.pdf 2/14/2011
AP02/8/2011N30894000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050824_omeprazole_clarithromycin_amoxicillin_toc.cfm 12/8/2011
AP02/8/2011N30895000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/050824Orig1s000SumR.pdf 12/8/2011
AP012/29/2014SLR41462004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050824Orig1s004ltr.pdf 12/31/2014
AP012/29/2014SLR41607004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050824s004lbl.pdf 1/9/2015
AP02/26/2016SCM       
AP010/24/2016SLR47444006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050824Orig1s006ltr.pdf 10/26/2016
AP010/24/2016SLR47523006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050824s006lbl.pdf 10/31/2016




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