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FDA Drug Application 050606 by ANI PHARMS INC

Application Number050606
Application Type New Drug Application
Sponsor ApplicantANI PHARMS INC
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
AP04/15/1986N       
AP06/5/1986SLR       
AP010/8/1986SCF       
AP08/12/1987SLR       
AP08/18/1987SCS       
AP05/23/1988SLR       
AP06/14/1996SLR       
AP09/27/1995SLR       
AP06/14/1996SLR       
AP06/30/1993SLR       
AP05/12/1997SLR       
AP03/18/1998SCM       
AP02/6/2001SLR       
AP05/24/2002SLR2199015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50606s015ltr.pdf 5/24/2002
AP05/28/2002SCE       
AP03/17/2004S8000019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50606slr019ltr.pdf 3/24/2004
AP05/27/2004SLR8857020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50606slr020_vancocin_lbl.pdf 6/1/2004
AP05/27/2004SLR8861020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50606slr020ltr.pdf 6/1/2004
AP01/8/2010SLR24513026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050606s026ltr.pdf 1/14/2010
AP012/14/2011SE830982028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050606s028lbl.pdf 12/14/2011
AP012/14/2011SE830999028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050606s028ltr.pdf 12/15/2011




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