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FDA Drug Application 018760 by ALVOGEN MALTA

Application Number018760
Application Type New Drug Application
Sponsor ApplicantALVOGEN MALTA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/8/1984N       
AP08/13/1984SCM       
AP08/20/1984SLR       
AP011/6/1984SCS       
AP011/19/1984SCS       
AP01/8/1985SCS       
AP06/17/1985SCF       
AP08/19/1985SCE       
AP09/20/1985SCF       
AP01/8/1987SCP       
AP04/26/1991SLR       
AP04/26/1991SLR       
AP04/26/1991SLR       
AP09/18/1991SLR       
AP08/5/1992SLR       
AP08/5/1992SLR       
AP04/29/1993SLR       
AP06/4/1993SLR       
AP05/4/1994SLR       
AP02/9/1996SLR       
AP010/11/1996SCP       
AP04/4/2000SLR3835022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/18240-s025_Tenormin.pdf 6/4/2001
AP07/21/1999SLR3832023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18240-s026_tenormin.pdf 6/4/2001
AP01/31/2003SLR3928024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18760slr024ltr.pdf 1/31/2003
AP010/30/2003SLR7020025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18760slr025ltr.pdf 12/2/2003
AP02/9/2005SLR11101026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18760s026ltr.pdf 2/11/2005
AP010/29/2008SLR21109027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018760s027ltr.pdf 10/30/2008
AP010/29/2008SLR21148027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018760s027lbl.pdf 11/7/2008
AP08/21/2011SLR29820028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018760s028ltr.pdf 8/18/2011
AP08/21/2011SLR29871028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018760s028lbl.pdf 8/24/2011
AP010/31/2012SLR34215029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018760Orig1s029ltr.pdf 11/1/2012
AP010/31/2012SLR34219029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018760s029lbl.pdf 11/2/2012




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