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FDA Drug Application 020353 by ALVOGEN MALTA

Application Number020353
Application Type New Drug Application
Sponsor ApplicantALVOGEN MALTA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/5/1996N30640000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM280324.pdf 11/17/2011
AP03/28/1996SLR6461001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020353s001_naprelan_toc.cfm 8/8/2003
AP01/31/1997SCS       
AP01/31/1997SCE       
AP05/12/1997SCE       
AP012/23/1997SCP       
AP011/2/1999SCS       
AP02/4/2002SLR       
AP07/20/1999SCP       
AP02/15/2000SCP       
AP06/15/2000SCS       
AP06/4/2001SCP       
AP010/2/2001SCM       
AP04/15/2002SCS       
AP01/18/2006SLR13430016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020353s016lbl.pdf 1/20/2006
AP01/18/2006SLR13470016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020353s016ltr.pdf 1/20/2006
AP05/29/2007SLR16678019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020353s019ltr.pdf 6/4/2007
AP07/8/2009SCM23153023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020353s023ltr.pdf 8/10/2009
AP07/8/2009SCM23747023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/20353s23lbl.pdf 11/6/2009
AP011/8/2011SLR30542028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020353s028lbl.pdf 11/9/2011
AP011/8/2011SLR30546028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020353s028ltr.pdf 11/10/2011
AP09/12/2014SCM       
AP05/9/2016SLR45987031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020353s031s032lbl.pdf 5/11/2016
AP05/9/2016SLR46010031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020353Orig1s031,s032ltr.pdf 5/12/2016
AP05/9/2016SLR45988032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020353s031s032lbl.pdf 5/11/2016
AP05/9/2016SLR46011032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020353Orig1s031,s032ltr.pdf 5/12/2016




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