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FDA Drug Application 016954 by JANSSEN PHARMS

Application Number016954
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
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
AP01/2/1973N       
AP03/6/1975SOA       
AP05/21/1975SOA       
AP05/21/1975SCS       
AP05/21/1975SCS       
AP05/21/1975SCS       
AP08/7/1975SCS       
AP08/7/1975SCS       
AP08/7/1975SCS       
AP08/7/1975SCS       
AP08/7/1975SCS       
AP08/7/1975SCS       
AP05/18/1976SCS       
AP05/18/1976SCS       
AP05/18/1976SCS       
AP03/29/1978SCS       
AP05/25/1978SCS       
AP04/17/1978SCS       
AP09/25/1978SCP       
AP06/21/1979SOA       
AP012/19/1978SLR       
AP010/19/1979SCP       
AP08/15/1979SLR       
AP011/8/1979SCS       
AP03/24/1980SCM       
AP08/21/1980SCM       
AP011/20/1980SCS       
AP09/29/1982SLR       
AP06/9/1983SCS       
AP06/15/1983SLR       
AP09/29/1983SLR       
AP01/30/1984SLR       
AP06/21/1984SCS       
AP04/5/1985SLR       
AP010/21/1985SLR       
AP011/23/1987SCS       
AP02/26/1987SLR       
AP09/9/1988SLR       
AP010/28/1988SCS       
AP07/19/1989SLR       
AP010/23/1989SLR       
AP01/18/1990SCS       
AP09/16/1991SLR       
AP07/26/1990SCS       
AP05/18/1993SCS       
AP011/4/1993SCM       
AP06/28/1994SLR       
AP09/7/1995SCS       
AP011/30/1995SCM       
AP04/9/1996SCS       
AP03/14/1996SLR       
AP01/14/1997SCS       
AP011/10/1999SLR       
AP04/13/1998SCM       
AP04/28/1998SCM       
AP01/5/2000SCP       
AP05/23/2000SCS       
AP05/24/2000SCS       
AP06/20/2002SCM       
AP010/1/2003SLR6738092   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16954slr092ltr.pdf 10/9/2003
AP06/20/2008SLR20059101   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016954s101ltr.pdf 6/24/2008
AP06/20/2008SLR20078101   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016954s101lbl.pdf 6/26/2008
AP06/18/2014SLR39591106   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016954Orig1s106ltr.pdf 6/19/2014
AP06/18/2014SLR39728106   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016954s106lbl.pdf 7/2/2014
AP09/11/2014SCM       




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