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FDA Drug Application 019257 by SIGMA TAU

Application Number019257
Application Type New Drug Application
Sponsor ApplicantSIGMA TAU
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/10/1986N       
AP08/29/1986SCS       
AP01/12/1989SCS       
AP05/11/1988SCF       
AP04/25/1990SCS       
AP05/12/1995SCS       
AP010/17/1995SCM       
AP01/27/1997SCS       
AP012/15/1998SLR       
AP04/15/2002SLR2309010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18948s22ltr.pdf 4/15/2002
AP04/15/2002SLR2310010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18948S22lbl.pdf 4/15/2002
AP03/28/2007SCF16124011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018948s024,019257s011lbl.pdf 3/31/2007
AP03/28/2007SCF16181011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018948s024,019257ltr.pdf 4/9/2007
AP05/29/2015SLR42965012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018948Orig1s026,019257Orig1s012,020182Orig1s013ltr.pdf 6/2/2015
AP05/29/2015SLR42998012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018948s026,019257s012,020182s013lbl.pdf 6/4/2015




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