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FDA Drug Application 020843 by ABBVIE INC

Application Number020843
Application Type New Drug Application
Sponsor ApplicantABBVIE 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
AP012/16/1998N367000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20843ltr.pdf 12/16/1998
AP012/16/1998N368000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20843lbl.pdf 12/16/1998
AP012/16/1998N11827000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020843_s000_PrometriumTOC.cfm 6/16/2005
AP010/15/1999SCS       
AP04/17/2000SCM       
AP04/17/2000SCM       
AP04/17/2000SCM       
AP012/10/2004SLR10786005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19781s005,006,20843s005,006lbl.pdf 12/10/2004
AP012/10/2004SLR10787005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19781s005,006,20843s005,006ltr.pdf 12/10/2004
AP012/10/2004SLR10784006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19781s005,006,20843s005,006lbl.pdf 12/10/2004
AP012/10/2004SLR10785006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19781s005,006,20843s005,006ltr.pdf 12/10/2004
AP06/27/2002SCS       
AP03/4/2004S7863008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19781slr008,20843slr008ltr.pdf 3/10/2004
AP06/30/2009SLR22873010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020843s010lbl.pdf 7/6/2009
AP06/30/2009SLR22883010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019781s013,020843s010ltr.pdf 7/7/2009
AP011/1/2011SLR30483011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019781s017,020843s011ltr.pdf 11/3/2011
AP011/1/2011SLR30491011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019781s017,020843s011lbl.pdf 11/4/2011
AP09/30/2014SCM       




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