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FDA Drug Application 018309 by TARO PHARMS NORTH

Application Number018309
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
AP03/28/1980N       
AP08/6/1980SCS       
AP07/6/1982SPD       
AP08/20/1981SCP       
AP06/8/1982SCP       
AP011/7/1983SCS       
AP011/1/1985SCS       
AP09/23/1986SCP       
AP02/19/1988SCM       
AP011/8/1988SCS       
AP04/27/2004SLR8431013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17856slr024,18309slr013ltr.pdf 4/29/2004
AP04/27/2004SLR8478013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17856slr024,18309slr013_topicort_lbl.pdf 5/4/2004
AP010/13/1993SCS       
AP07/26/1994SCM       
AP01/25/1996SCM       
AP09/15/1998SCM       




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