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FDA Drug Application 018613 by TARO PHARMS NORTH

Application Number018613
Application Type New Drug Application
Sponsor ApplicantTARO PHARMS NORTH
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/2/1982N       
AP012/2/1988SLR       
AP03/27/1985SCM       
AP05/13/1987SCM       
AP07/14/1989SLR       
AP04/30/1999SCM3085009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18613s009s010_ovide.pdf 4/30/1999
AP04/30/1999SLR3086010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18613s009s010_ovide.pdf 4/30/1999
AP04/4/2003SLR4928011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018613s011lbl.pdf 4/4/2003
AP04/4/2003SLR5316011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18613slr011ltr.pdf 4/16/2003
AP012/9/2011SLR30972017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018613s017ltr.pdf 12/14/2011
AP012/9/2011SLR30988017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018613s017lbl.pdf 12/14/2011




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