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FDA Drug Application 020193 by JANSSEN PHARMS

Application Number020193
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 CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/26/1996N       
AP011/8/2001SCS32656002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020193Orig1s002.pdf 5/9/2012
AP08/24/2004SLR10054003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20193s003ltr.pdf 8/25/2004
AP08/24/2004SLR10073003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20193s003lbl.pdf 8/25/2004
AP09/20/2006SLR14933004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020193s004lbl.pdf 9/21/2006
AP09/20/2006SLR14948004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020193s004ltr.pdf 9/25/2006
AP07/24/2008SLR20300007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020193s007ltr.pdf 7/29/2008
AP07/24/2008SLR20313007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020193s007lbl.pdf 7/29/2008
AP012/15/2008SLR21394009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020193s009ltr.pdf 12/23/2008
AP012/15/2008SLR21481009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020193s009lbl.pdf 1/2/2009




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