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FDA Drug Application 019964 by JANSSEN PHARMS

Application Number019964
Application Type New Drug Application
Sponsor ApplicantJANSSEN PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/21/1991N       
AP03/11/1992SCS       
AP09/25/1992SCM       
AP02/9/1993SCS       
AP010/17/1994SCS       
AP07/28/1997SLR       
AP010/7/1998SCP       
AP010/28/1999SCM       
AP010/8/1999SCM       
AP010/8/1999SCS       
AP03/11/2003SLR4440011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf 3/20/2003
AP03/11/2003SLR4472011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr016,020,19641slr016,018,19964slr011,014ltr.pdf 3/25/2003
AP03/13/2001SCP       
AP09/21/2001SCS       
AP03/11/2003SLR4441014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf 3/20/2003
AP03/11/2003SLR4473014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr016,020,19641slr016,018,19964slr011,014ltr.pdf 3/25/2003
AP012/10/2001SCS       
AP04/16/2002SCS       
AP010/4/2002SCS       
AP09/24/2003SLR6726020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr025,19964slr020ltr.pdf 9/30/2003
AP06/30/2004SLR9647021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19579slr026,19641slr022,19964slr021ltr.pdf 6/30/2004
AP06/30/2004SLR9706021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19579slr026,19641slr022,19964slr021_terazol_lbl.pdf 7/1/2004
AP09/26/2013SLR37241030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019579s035,019641s028,019964s030lbl.pdf 9/27/2013
AP09/26/2013SLR37266030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019579Orig1s035,019641s028,019964Orig1s030ltr.pdf 10/1/2013
AP07/23/2013SCM       
AP07/23/2014SLR39979032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019579s037,019641s030,019964s032lbl.pdf 7/24/2014
AP07/23/2014SLR40002032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019579Orig1s037,019641Orig1s030,019964Orig1s032ltr.pdf 7/25/2014




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