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FDA Drug Application 050739 by ABBVIE

Application Number050739
Application Type New Drug Application
Sponsor ApplicantABBVIE
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
AP012/4/1997N13319000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050739s000_050749s000_OmnicefTOC.cfm 1/3/2006
AP01/13/1998SCE       
AP011/8/1999SE22898002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50739S2LTR.PDF 11/24/1999
AP011/8/1999SE22899002   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50739S2LBL.PDF 11/24/1999
AP011/9/2000SCP       
AP06/18/2001SCM       
AP07/24/2002SLR2677006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50739slr006ltr.pdf 7/24/2002
AP09/2/2004SLR10115007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50749s009,50739s007ltr.pdf 9/3/2004
AP07/19/2005SLR12034010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050739s010,050749s013ltr.pdf 7/21/2005
AP07/19/2005SLR12040010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050739s010,050749s013lbl.pdf 7/21/2005
AP06/15/2007SLR16831013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf 6/27/2007
AP06/15/2007SLR16931013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050739s013, 050749s017ltr.pdf 7/5/2007
AP09/14/2007SLR17903014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s014,050749s018lbl.pdf 9/19/2007
AP09/14/2007SLR17994014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050739s014, 050749s018ltr.pdf 9/25/2007
AP012/15/2008SLR21378015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050739s015, 050749s021ltr.pdf 12/19/2008
AP012/15/2008SLR21476015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050739s015,050749s021lbl.pdf 1/2/2009
AP011/18/2015SLR44527017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050739s017,050749s023lbl.pdf 11/19/2015
AP011/18/2015SLR44555017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050739Orig1s017,050749Orig1s023ltr.pdf 11/20/2015




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