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FDA Drug Application 020075 by SAOL THERAPS RES LTD

Application Number020075
Application Type New Drug Application
Sponsor ApplicantSAOL THERAPS RES LTD
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
AP06/17/1992N       
AP05/20/1994SCP       
AP06/14/1996SE1       
AP011/7/1996SCF       
AP03/3/2000SCM       
AP06/23/1998SCM       
AP08/21/1998SCM       
AP08/21/1998SCE       
AP05/5/1999SCM       
AP03/6/2002SLR3403014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20075s14s16ltr.pdf 3/6/2002
AP05/3/2001SCS       
AP03/6/2002SLR3404016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20075s14s16ltr.pdf 3/6/2002
AP011/21/2002SCP3402017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20075scp017ltr.pdf 11/20/2002
AP012/10/2002SCM       
AP01/17/2003SCM3761019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20075scm019ltr.pdf 1/17/2003
AP05/8/2003SCP5771020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20075scp020ltr.pdf 5/30/2003
AP03/25/2011SLR28398021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020075s021lbl.pdf 3/29/2011
AP03/25/2011SLR28400021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020075s021ltr.pdf 3/29/2011
AP011/13/2011SLR30602024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020075s024ltr.pdf 11/16/2011
AP011/13/2011SLR30628024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020075s024lbl.pdf 11/16/2011
AP01/10/2013SCM       
AP03/6/2013SCM35387026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020075s026lbl.pdf 3/8/2013
AP09/5/2013SCM       
AP011/19/2013SLR37865028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020075Orig1s028ltr.pdf 11/20/2013
AP011/19/2013SLR37890028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020075s028lbl.pdf 11/22/2013
AP06/7/2016SCM       
AP06/5/2014SCM       
AP011/19/2014SLR41066031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020075Orig1s031ltr.pdf 11/21/2014
AP09/30/2016SLR47265032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020075Orig1s032ltr.pdf 10/4/2016
AP09/30/2016SLR47304032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020075s032lbl.pdf 10/6/2016




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