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FDA Drug Application 020182 by SIGMA TAU

Application Number020182
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
AP012/16/1992N       
AP08/7/1995SLR       
AP08/10/1995SCP       
AP01/27/1997SCS       
AP012/1/1997SCS       
AP012/15/1998SLR       
AP012/15/1999SE14552006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20182s6_Carnitor_prntlbl.pdf 12/15/1999
AP012/15/1999SE12305006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20182S6LTR.PDF 12/15/1999
AP012/15/1999SE12306006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20182S6_Carnitor.cfm 12/15/1999
AP05/16/2000SCM       
AP04/15/2002SLR2311008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18948s22ltr.pdf 4/15/2002
AP04/15/2002SLR2312008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18948S22lbl.pdf 4/15/2002
AP05/29/2015SLR42966013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018948Orig1s026,019257Orig1s012,020182Orig1s013ltr.pdf 6/2/2015
AP05/29/2015SLR42997013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018948s026,019257s012,020182s013lbl.pdf 6/4/2015




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