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FDA Drug Application 021234 by INST BIOCHEM

Application Number021234
Application Type New Drug Application
Sponsor ApplicantINST BIOCHEM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/31/2007N15741000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021234lbl.pdf 2/2/2007
AP01/31/2007N15788000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021234s000ltr.pdf 2/12/2007
AP01/31/2007N15838000   http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM106241.pdf 2/20/2007
AP01/31/2007N18938000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021234s000TOC.cfm 1/23/2008
AP06/4/2008SLR19961003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021234s003ltr.pdf 6/6/2008
AP06/4/2008SLR20042003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021234s003lbl.pdf 6/19/2008
AP010/23/2008SLR21087004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021234s004ltr.pdf 10/28/2008
AP01/31/2011SLR27649005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021234s005lbl.pdf 1/31/2011
AP01/31/2011SLR27710005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021234s005,s008ltr.pdf 2/4/2011
AP09/3/2009SLR23536006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021234s006s007lbl.pdf 10/6/2009
AP09/3/2009SLR23788006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021234s006ltr.pdf 11/10/2009
AP09/3/2009SLR23537007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021234s006s007lbl.pdf 10/6/2009
AP01/31/2011SLR27711008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021234s005,s008ltr.pdf 2/4/2011
AP01/31/2011SLR27739008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021234s005s008MedG.pdf 2/4/2011
AP02/23/2011SLR27975009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021234s009ltr.pdf 2/28/2011
AP02/23/2011SLR28035009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021234s009MedG.pdf 3/4/2011
AP02/23/2011SLR28036009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021234s009lbl.pdf 3/4/2011
AP05/8/2013SCM       
AP05/9/2016SLR45914013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021234Orig1s013,s014ltr.pdf 5/11/2016
AP05/9/2016SLR45973013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021234s013s014lbl.pdf 5/11/2016
AP05/9/2016SLR45915014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021234Orig1s013,s014ltr.pdf 5/11/2016
AP05/9/2016SLR45974014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021234s013s014lbl.pdf 5/11/2016




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