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FDA Drug Application 016620 by ALVOGEN MALTA

Application Number016620
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
AP06/5/1970N       
AP07/15/1976SCP17223016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S016_Macrodantin Capsules.pdf 7/9/2007
AP07/21/1976SCM17224017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S017_Macrodantin Capsules.pdf 7/9/2007
AP07/21/1976SCP17217018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S018_Macodantin.pdf 7/9/2007
AP011/22/1976SCP17215019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S019_Macrodantin Capsules.pdf 7/9/2007
AP03/21/1977SCS17216020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S020_Macrodantin Capsules.pdf 7/9/2007
AP05/13/1977SCS       
AP07/28/1978SLR       
AP07/26/1979SCP       
AP012/18/1979SLR       
AP07/16/1979SCM       
AP05/20/1980SCP       
AP08/14/1980SCF       
AP010/15/1982SLR       
AP012/12/1980SLR       
AP05/13/1982SCP       
AP05/18/1993SLR       
AP06/2/1983SCM       
AP07/9/1984SCM       
AP05/19/1993SLR       
AP05/13/1988SLR14082045   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/008693s025_009175s019_016620s045_MacrodantinTOC.cfm 5/10/2006
AP01/3/1989SCM15843047   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/16620_S047_MacrodantinTOC.cfm 2/20/2007
AP09/11/1990SCM       
AP07/9/1990SCP       
AP04/10/1991SCS       
AP012/8/1992SCM       
AP012/8/1992SCP19149053   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S053_MACRODANTIN.pdf 2/19/2008
AP012/8/1992SCF19150054   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S054_MACRODANTIN.pdf 2/19/2008
AP012/8/1992SCS19152055   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S055_MACRODANTIN.pdf 2/19/2008
AP02/17/1998SLR       
AP08/9/1993SCS19151057   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S057_MACRODANTIN.pdf 2/19/2008
AP02/17/1998SLR       
AP03/7/1996SCS19153059   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016620_S059_MACRODANTIN.pdf 2/19/2008
AP07/30/1996SCM       
AP03/27/1997SLR       
AP07/16/1997SLR20566062   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/016620_S062_MACRODANTIN.pdf 8/11/2008
AP010/21/1998SCS20554063   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/016620_S063_MACRODANTIN.pdf 8/11/2008
AP02/4/2003SLR20396064   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/016620_S064_MACRODANTIN.pdf 8/1/2008
AP02/4/2003SLR4769064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16620slr064ltr.pdf 2/4/2003
AP03/29/2004SLR8288065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16620slr065_mecrodantin_lbl.pdf 4/5/2004
AP03/29/2004SLR8316065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16620slr065ltr.pdf 4/7/2004
AP03/29/2004SLR20390065   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/016620_S065_MACRODANTIN.pdf 7/31/2008
AP09/14/2007SLR17904067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016620s067lbl.pdf 9/19/2007
AP09/14/2007SLR17944067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016620s067ltr.pdf 9/25/2007
AP03/5/2009SLR21964068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016620s068ltr.pdf 3/6/2009
AP03/5/2009SLR22013068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016620s068lbl.pdf 3/17/2009
AP06/6/2011SLR29071070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016620s070,020064s020ltr.pdf 6/9/2011
AP09/6/2013SLR37006072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016620s072lbl.pdf 9/9/2013
AP09/6/2013SLR37039072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016620Orig1s072ltr.pdf 9/10/2013
AP010/2/2015SCM       
AP010/15/2015SCM       




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