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FDA Drug Application 020281 by JANSSEN PHARMS

Application Number020281
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
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
AP03/3/1995N       
AP010/20/1995SCM       
AP012/22/1995SCP       
AP012/22/1995SCM       
AP03/20/1996SLR       
AP03/20/1996SLR       
AP03/20/1996SLR       
AP03/20/1996SLR       
AP03/20/1996SLR       
AP011/27/1996SCM       
AP010/30/1996SCM       
AP011/20/1997SLR       
AP011/20/1997SLR       
AP08/21/1998SE16432014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020281s014_ultram_toc.cfm 8/7/2003
AP08/21/1998SE19604014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20281-S014_ULTRAM_APPROV.PDF 6/29/2004
AP08/21/1998SLR6433015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020281s015_ultram_toc.cfm 8/7/2003
AP08/21/1998SLR9603015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20281-S015_ULTRAM_APPROV.PDF 6/29/2004
AP012/23/1999SE21235016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20281S16LTR.PDF 12/23/1999
AP012/23/1999SE21236016   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20281S16LBL.PDF 12/23/1999
AP08/20/1999SCP       
AP03/21/2000SCM       
AP03/8/2000SCP       
AP04/10/2000SCM       
AP06/2/2000SCM       
AP02/13/2001SCM       
AP08/15/2001SLR5406029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20281s29lbl.pdf 4/22/2003
AP04/16/2004SLR8369030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20281slr030,21123slr001ltr.pdf 4/20/2004
AP04/16/2004SLR8471030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20281slr030,21123slr001_Ultram_lbl.pdf 5/3/2004
AP09/9/2009SLR23539032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020281s032s033lbl.pdf 10/6/2009
AP09/9/2009SLR23844032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020281s032,s033ltr.pdf 11/12/2009
AP09/9/2009SLR23845033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020281s032,s033ltr.pdf 11/12/2009
AP09/9/2009SLR23540033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020281s032s033lbl.pdf 10/6/2009




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