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FDA Drug Application 018240 by ALVOGEN MALTA

Application Number018240
Application Type New Drug Application
Sponsor ApplicantALVOGEN MALTA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/19/1981N       
AP09/23/1981SLR       
AP09/4/1985SE1       
AP04/7/1983SCF       
AP09/27/1983SCP       
AP09/13/1989SE1       
AP012/15/1983SCS       
AP07/12/1984SCM       
AP011/19/1984SCS       
AP09/18/1985SLR       
AP02/13/1987SCP       
AP04/9/1990SE2       
AP02/21/1991SLR       
AP02/21/1991SLR       
AP02/21/1991SLR       
AP09/18/1991SLR       
AP08/5/1992SLR       
AP08/5/1992SLR       
AP04/29/1993SLR       
AP05/4/1994SLR       
AP02/9/1996SLR       
AP010/11/1996SCP       
AP04/4/2000SLR3834025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/18240-s025_Tenormin.pdf 6/4/2001
AP07/21/1999SLR3831026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18240-s026_tenormin.pdf 6/4/2001
AP01/9/2003SLR3929027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18240slr027ltr.pdf 1/9/2003
AP011/6/2003SLR6902028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18240slr028,19058slr016ltr.pdf 11/13/2003
AP02/9/2005SLR11102029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18240s029ltr.pdf 2/11/2005
AP04/29/2008SLR19758030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018240s030ltr.pdf 5/5/2008
AP08/17/2011SLR29822031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018240s031ltr.pdf 8/18/2011
AP08/17/2011SLR29870031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018240s031lbl.pdf 8/24/2011
AP010/31/2012SLR34238032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018240Orig1s032ltr.pdf 11/5/2012
AP010/31/2012SLR34292032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018240s032lbl.pdf 11/6/2012
AP07/9/2015SCM       
AP07/15/2015SCM       
AP07/16/2015SCM       
AP08/27/2015SCM       
AP09/3/2015SCM       
AP09/10/2015SCM       




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