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FDA Drug Application 074286 by TARO

Application Number074286
Application Type Abbreviated New Drug Application
Sponsor ApplicantTARO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/7/1996N       
AP09/17/1996SC32231001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1996/074286Orig1s001.pdf 3/27/2012
AP07/18/1997SC32232002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/074286Orig1s002.pdf 3/27/2012
AP04/9/1999SC32282003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074286Orig1s003.pdf 3/29/2012
AP05/16/2000SCC32281004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/074286Orig1s004.pdf 3/29/2012
AP012/19/2003SLR32280006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/074286Orig1s006.pdf 3/29/2012
AP04/26/2004SCM32279007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/074286Orig1s007.pdf 3/29/2012
AP04/24/2004SLR32278008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/074286Orig1s008.pdf 3/29/2012
AP011/23/2004SLR32277009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/074286Orig1s009.pdf 3/29/2012
AP09/15/2005SCM32276010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/074286Orig1s010.pdf 3/29/2012
AP07/25/2008SCM32275012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/074286Orig1s012.pdf 3/29/2012
AP07/25/2008SCM32274013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/074286Orig1s013.pdf 3/29/2012
AP03/15/2010SCM32273016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/074286Orig1s016.pdf 3/29/2012
AP03/20/2013SLR41495017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/074286Orig1s017lbl.pdf 1/6/2015
AP03/20/2013SLR41512017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/074286Orig1s017ltr.pdf 1/7/2015




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