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FDA Drug Application 020064 by ALVOGEN MALTA

Application Number020064
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
AP012/24/1991N       
AP07/24/1992SCS       
AP02/20/1996SLR       
AP08/9/1993SCS       
AP08/23/1993SCS       
AP02/17/1998SLR       
AP02/13/1995SCM       
AP03/27/1997SLR       
AP07/16/1997SLR       
AP02/17/1998SLR       
AP09/15/1999SCP       
AP011/3/1999SCM       
AP02/4/2003SLR4768013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20064slr013ltr.pdf 2/4/2003
AP010/30/2003SLR6867014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20064slr014ltr.pdf 11/5/2003
AP010/30/2003SLR6883014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20064slr014_macrobid_lbl.pdf 11/5/2003
AP06/27/2007SLR16885017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020064s017ltr.pdf 7/5/2007
AP03/5/2009SLR21963019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020064s019ltr.pdf 3/6/2009
AP03/5/2009SLR22034019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020064s019lbl.pdf 3/17/2009
AP06/6/2011SLR29072020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016620s070,020064s020ltr.pdf 6/9/2011
AP09/6/2013SLR37005021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020064s021lbl.pdf 9/9/2013
AP09/6/2013SLR37040021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020064Orig1s021ltr.pdf 9/11/2013
AP01/7/2014SCM       




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