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FDA Drug Application 018763 by TARO PHARMS NORTH

Application Number018763
Application Type New Drug Application
Sponsor ApplicantTARO PHARMS NORTH
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
AP010/3/1983N       
AP02/18/1988SCM       
AP04/27/2004SLR8436003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18763slr003ltr.pdf 4/29/2004
AP04/27/2004SLR8481003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18763slr003_topicort_lbl.pdf 5/4/2004
AP010/13/1993SCS       
AP07/26/1994SCM       
AP01/19/1996SCS       
AP01/25/1996SCM       
AP02/18/1998SCM       




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