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FDA Drug Application 050749 by ABBVIE

Application Number050749
Application Type New Drug Application
Sponsor ApplicantABBVIE
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
AP012/4/1997N13320000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050739s000_050749s000_OmnicefTOC.cfm 1/3/2006
AP04/22/1998SCS       
AP07/14/1999SE2972002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50749s02ltr.pdf 7/14/1999
AP07/14/1999SE2973002   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50749s02lbl.pdf 7/14/1999
AP07/13/1999SLR       
AP06/18/2001SCM       
AP09/2/2004SLR10114009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50749s009,50739s007ltr.pdf 9/3/2004
AP07/29/2004SCS9911010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50749s010ltr.pdf 7/30/2004
AP07/19/2005SLR12033013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050739s010,050749s013ltr.pdf 7/21/2005
AP07/19/2005SLR12039013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050739s010,050749s013lbl.pdf 7/21/2005
AP06/15/2007SLR16832017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s013,050749s017lbl.pdf 6/27/2007
AP06/15/2007SLR16930017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050739s013, 050749s017ltr.pdf 7/5/2007
AP09/14/2007SLR17902018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050739s014,050749s018lbl.pdf 9/19/2007
AP09/14/2007SLR17995018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050739s014, 050749s018ltr.pdf 9/25/2007
AP012/15/2008SLR21379021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050739s015, 050749s021ltr.pdf 12/19/2008
AP012/15/2008SLR21477021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050739s015,050749s021lbl.pdf 1/2/2009
AP011/18/2015SLR44526023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050739s017,050749s023lbl.pdf 11/19/2015
AP011/18/2015SLR44556023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050739Orig1s017,050749Orig1s023ltr.pdf 11/20/2015




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