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FDA Drug Application 021143 by TARO

Application Number021143
Application Type New Drug Application
Sponsor ApplicantTARO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/12/2000N1339000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21143ltr.pdf 4/12/2000
AP04/12/2000N1340000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21143lbl.pdf 4/12/2000
AP04/12/2000N4098000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21143_Trivagizole3.cfm 7/30/2001
AP010/18/2000SCP       
AP01/10/2001SCS       
AP09/17/2001SCS       
AP011/8/2002SCS       
AP012/10/2002SCP       
AP05/15/2014SCM       
AP08/25/2016SLR46897012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021143Orig1s012ltr.pdf 8/29/2016
AP08/25/2016SLR46917012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021143Orig1s012lbl.pdf 8/30/2016




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