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FDA Drug Application 022456 by SANTARUS

Application Number022456
Application Type New Drug Application
Sponsor ApplicantSANTARUS
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
AP012/4/2009N24468000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022456s000ltr.pdf 1/7/2010
AP012/4/2009N24469000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022456lbl.pdf 1/7/2010
AP012/4/2009N25109000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022456_magnsium_hydroxide_omeprazole_sodium_bicarbonate_toc.cfm 3/25/2010
AP012/4/2009N25110000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022456s000sumr.pdf 3/25/2010
AP09/3/2010SLR26426002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s009,021849s004,021850s003,022456s002ltr.pdf 9/8/2010
AP09/3/2010SLR26466002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,021850s003,022456s002lbl.pdf 9/10/2010
AP05/20/2011SLR28936003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022456s003ltr.pdf 5/25/2011
AP012/7/2011SLR30929004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022456s004ltr.pdf 12/13/2011
AP012/7/2011SLR30986004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022456s004lbl.pdf 12/14/2011
AP012/11/2012SLR34618005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022456s005lbl.pdf 12/13/2012
AP012/11/2012SLR34656005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022456Orig1s005ltr.pdf 12/13/2012
AP05/23/2012SLR32761006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022456s006ltr.pdf 5/24/2012
AP05/23/2012SLR32771006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022456s006lbl.pdf 5/29/2012




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