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FDA Drug Application 018948 by SIGMA TAU

Application Number018948
Application Type New Drug Application
Sponsor ApplicantSIGMA TAU
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/27/1985N       
AP04/27/1988SCF       
AP09/16/1988SLR       
AP03/22/1989SCF       
AP012/7/1989SCF       
AP012/7/1989SCP       
AP012/16/1992SE1       
AP02/21/1992SLR       
AP05/11/1993SCM       
AP04/13/1994SCS       
AP04/14/1992SCS       
AP07/22/1992SLR       
AP07/14/1992SLR3726016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018948a_s016_071492.pdf 5/7/1998
AP012/20/1995SCP       
AP04/16/1996SCS       
AP01/27/1997SCS       
AP010/21/1997SCM       
AP012/15/1998SLR       
AP04/15/2002SLR2307022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18948s22ltr.pdf 4/15/2002
AP04/15/2002SLR2308022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18948S22lbl.pdf 4/15/2002
AP03/28/2007SLR16125024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018948s024,019257s011lbl.pdf 3/31/2007
AP03/28/2007SLR16182024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018948s024,019257ltr.pdf 4/9/2007
AP02/22/2013SCM       
AP05/29/2015SLR42964026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018948Orig1s026,019257Orig1s012,020182Orig1s013ltr.pdf 6/2/2015
AP05/29/2015SLR42999026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018948s026,019257s012,020182s013lbl.pdf 6/4/2015




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