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FDA Drug Application 020229 by JANSSEN PHARMS

Application Number020229
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 Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/26/1993N       
AP07/28/1993SCS       
AP09/1/1994SCM       
AP03/16/1994SCM       
AP08/20/2002SLR4761004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20229slr004,007ltr.pdf 8/20/2002
AP04/18/1996SCS       
AP010/23/1996SCS       
AP08/20/2002SLR2787007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20229slr004,007ltr.pdf 8/20/2002
AP04/18/1997SCS       
AP07/24/1997SCE       
AP07/24/1997SCS       
AP07/24/1997SCS       
AP07/28/1997SCM       
AP09/18/1997SCS       
AP012/3/1997SCM       
AP012/29/1997SCS       
AP02/9/1998SCM       
AP02/26/1998SCS       
AP02/18/1998SCS       
AP07/14/1998SCE       
AP07/14/1998SCM       
AP08/22/2002SLR2786021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20229slr021ltr.pdf 8/22/2002
AP02/9/2000SCM       
AP04/11/2000SCM       
AP010/24/2000SCS       
AP01/19/2001SCS       
AP011/7/2001SCM       
AP011/7/2001SCS       
AP04/23/2002SCS       
AP06/29/2006SLR14403030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020229s030ltr.pdf 7/3/2006
AP08/2/2012SLR33353034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020229s034lbl.pdf 8/3/2012
AP08/2/2012SLR33366034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020229Orig1s034ltr.pdf 8/3/2012




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