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FDA Drug Application 019641 by JANSSEN PHARMS

Application Number019641
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
AP05/24/1988N       
AP011/3/1988SLR       
AP011/30/1989SLR       
AP07/25/1989SCS       
AP08/21/1990SCM       
AP09/25/1992SCM       
AP02/9/1993SCS       
AP010/17/1994SCS       
AP07/28/1997SLR       
AP010/7/1998SCP       
AP011/1/1999SCM       
AP09/29/1999SCS       
AP010/8/1999SCM       
AP010/8/1999SCS       
AP03/11/2003SLR4436016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf 3/20/2003
AP03/11/2003SLR4470016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr016,020,19641slr016,018,19964slr011,014ltr.pdf 3/25/2003
AP09/21/2001SCS       
AP03/11/2003SLR4437018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf 3/20/2003
AP03/11/2003SLR4471018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr016,020,19641slr016,018,19964slr011,014ltr.pdf 3/25/2003
AP012/10/2001SCS       
AP010/4/2002SCS       
AP06/30/2004SLR9646022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19579slr026,19641slr022,19964slr021ltr.pdf 6/30/2004
AP06/30/2004SLR9705022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19579slr026,19641slr022,19964slr021_terazol_lbl.pdf 7/1/2004
AP09/26/2013SLR37242028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019579s035,019641s028,019964s030lbl.pdf 9/27/2013
AP09/26/2013SLR37265028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019579Orig1s035,019641s028,019964Orig1s030ltr.pdf 10/1/2013
AP07/23/2013SCM       
AP07/23/2014SLR39980030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019579s037,019641s030,019964s032lbl.pdf 7/24/2014
AP07/23/2014SLR40001030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019579Orig1s037,019641Orig1s030,019964Orig1s032ltr.pdf 7/25/2014




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