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FDA Drug Application 022032 by DEXCEL PHARMA

Application Number022032
Application Type New Drug Application
Sponsor ApplicantDEXCEL PHARMA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA06/14/2007TA22643000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022032_omeprazole_toc.cfm 5/28/2009
AP112/4/2007N22643000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022032_omeprazole_toc.cfm 5/28/2009
TA06/14/2007TA22644000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022032s000_SumR.pdf 5/28/2009
AP112/4/2007N22644000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022032s000_SumR.pdf 5/28/2009
TA06/14/2007TA16927000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022032s000TAltr.pdf 7/5/2007
AP112/4/2007N16927000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022032s000TAltr.pdf 7/5/2007
TA06/14/2007TA18860000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022032s000ltr.pdf 1/9/2008
AP112/4/2007N18860000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022032s000ltr.pdf 1/9/2008
AP04/2/2009SLR22221003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022032s003ltr.pdf 4/7/2009
AP17/16/2009SO22221003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022032s003ltr.pdf 4/7/2009
AP04/2/2009SLR23021003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022032s003GenAdviceltr.pdf 7/23/2009
AP17/16/2009SO23021003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022032s003GenAdviceltr.pdf 7/23/2009
AP04/2/2009SLR23069003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022032s003lbl.pdf 7/24/2009
AP17/16/2009SO23069003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022032s003lbl.pdf 7/24/2009
AP07/16/2010SLR25998008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022032s008ltr.pdf 7/23/2010
AP06/27/2011SLR29391012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022032s012ltr.pdf 7/5/2011
AP04/9/2012SLR32402016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022032s016ltr.pdf 4/11/2012
AP09/10/2012SLR33698019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022032Orig1s019ltr.pdf 9/11/2012
AP010/29/2012SLR34203020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022032Orig1s020ltr.pdf 10/30/2012
AP010/29/2012SLR38279020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022032Orig1s020lbl.pdf 1/15/2014
AP08/16/2013SLR36843021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022032Orig1s021ltr.pdf 8/20/2013
AP08/16/2013SLR37166021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022032Orig1s021lbl.pdf 9/19/2013
AP09/13/2013SCM       
AP08/2/2016SCM       
AP03/6/2015SCM42072024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022032Orig1s024ltr.pdf 3/10/2015
AP03/6/2015SCM42130024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022032Orig1s024lbl.pdf 3/12/2015
AP01/5/2016SCM       
AP08/7/2015SCM       
AP03/30/2015SCM       
AP06/1/2015SCM       
AP06/11/2015SLR43049029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022032Orig1s029ltr.pdf 6/12/2015
AP06/11/2015SLR43076029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022032Orig1s029lbll.pdf 6/19/2015
AP02/8/2016SCM       
AP02/10/2016SLR45146032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022032Orig1s032ltr.pdf 2/11/2016
AP02/10/2016SLR45147032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022032Orig1s032lbl.pdf 2/11/2016




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