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FDA Drug Application 018337 by TARO PHARMS NORTH

Application Number018337
Application Type New Drug Application
Sponsor ApplicantTARO PHARMS NORTH
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
AP04/22/1980N       
AP06/8/1988SL       
AP01/28/1993SCS       
AP08/26/1992SLR32291013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018337Orig1s013.pdf 3/30/2012
AP06/15/1994SCM       
AP09/21/2000SCS       
AP010/9/2002SCS       
AP011/2/2007SCM18361024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018337s024ltr.pdf 11/8/2007
AP06/27/2008SCM20137025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018337s025ltr.pdf 7/1/2008
AP04/5/2010SLR25230028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018337s028ltr.pdf 4/8/2010
AP010/20/2010SLR       
AP01/16/2014SLR38315032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018337Orig1s032ltr.pdf 1/17/2014
AP01/16/2014SLR38396032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018337Orig1s032lbl.pdf 1/28/2014
AP01/5/2015SCM       
AP08/12/2015SLR43639034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018337Orig1s034ltr.pdf 8/13/2015
AP08/12/2015SLR43642034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018337Orig1s034lbl.pdf 8/13/2015




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