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FDA Drug Application 017856 by TARO PHARMS NORTH

Application Number017856
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
AP02/28/1977N       
AP010/21/1977SCP       
AP06/30/1978SLR       
AP07/3/1979SCP       
AP07/23/1979SCS       
AP010/22/1979SCS       
AP010/23/1979SCM       
AP010/23/1979SCS       
AP010/23/1979SCS       
AP010/9/1980SCS       
AP07/6/1982SPD       
AP08/20/1981SCS       
AP08/20/1981SCM       
AP08/20/1981SCE       
AP06/8/1982SCP       
AP011/7/1983SCS       
AP011/1/1985SCS       
AP09/25/1986SCS       
AP02/19/1988SCM       
AP011/8/1988SCS       
AP04/27/2004SLR8430024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17856slr024,18309slr013ltr.pdf 4/29/2004
AP04/27/2004SLR8477024   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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