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FDA Drug Application 021123 by JANSSEN PHARMS

Application Number021123
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
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
AP08/15/2001N1872000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21123_Ultracet.cfm 8/15/2001
AP08/15/2001N5190000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21123_Ultracet_Approv.pdf 8/15/2001
AP08/15/2001N5191000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21123lbl.pdf 8/15/2001
AP04/16/2004SLR8370001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20281slr030,21123slr001ltr.pdf 4/20/2004
AP04/16/2004SLR8472001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20281slr030,21123slr001_Ultram_lbl.pdf 5/3/2004
AP09/9/2009SLR23392003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021123s003lbl.pdf 9/17/2009
AP09/9/2009SLR23797003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021123s003ltr.pdf 11/10/2009
AP06/22/2011SLR29302005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021123s005ltr.pdf 6/28/2011
AP06/22/2011SLR29348005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021123s005lbl.pdf 6/29/2011
AP010/18/2013SLR37485008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021123Orig1s008ltr.pdf 10/21/2013
AP010/18/2013SLR37525008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021123s008lbl.pdf 10/22/2013




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