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FDA Drug Application 019579 by JANSSEN PHARMS

Application Number019579
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
AP012/31/1987N       
AP012/6/1989SLR       
AP04/3/1989SCE       
AP012/6/1989SLR       
AP07/28/1989SCS       
AP08/21/1990SCM       
AP08/21/1990SCS       
AP09/24/1992SCM       
AP02/9/1993SCS       
AP010/17/1994SCS       
AP07/28/1997SLR       
AP010/7/1998SCP       
AP011/1/1999SCM       
AP010/8/1999SCM       
AP010/8/1999SCS       
AP03/11/2003SLR4438016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf 3/20/2003
AP03/11/2003SLR4469016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr016,020,19641slr016,018,19964slr011,014ltr.pdf 3/25/2003
AP02/22/2000SCS       
AP03/13/2001SCP       
AP09/21/2001SCS       
AP03/11/2003SLR4439020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf 3/20/2003
AP03/11/2003SLR4468020   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       
AP09/24/2003SLR6725025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr025,19964slr020ltr.pdf 9/30/2003
AP06/30/2004SLR9645026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19579slr026,19641slr022,19964slr021ltr.pdf 6/30/2004
AP06/30/2004SLR9704026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19579slr026,19641slr022,19964slr021_terazol_lbl.pdf 7/1/2004
AP09/26/2013SLR37243035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019579s035,019641s028,019964s030lbl.pdf 9/27/2013
AP09/26/2013SLR37264035   http://www.accessdata.fda.gov/drugsatfda_docs/2013/019579Orig1s035,019641s028,019964Orig1s030ltr.pdf 10/1/2013
AP07/23/2013SCM       
AP07/23/2014SLR39981037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019579s037,019641s030,019964s032lbl.pdf 7/24/2014
AP07/23/2014SLR40000037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019579Orig1s037,019641Orig1s030,019964Orig1s032ltr.pdf 7/25/2014




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