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FDA Drug Application 013263 by ROCHE

Application Number013263
Application Type New Drug Application
Sponsor ApplicantROCHE
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
AP011/15/1963N       
AP012/13/1974SCS       
AP01/24/1975SCS       
AP06/18/1975SCS       
AP08/25/1975SCS       
AP08/27/1976SLR       
AP010/27/1976SLR       
AP012/14/1976SLR       
AP09/21/1977SLR       
AP03/30/1978SLR       
AP02/26/1980SCS       
AP04/4/1979SCP       
AP011/2/1979SLR       
AP09/20/1979SCF       
AP01/9/1981SCF       
AP05/19/1980SLR       
AP06/17/1980SCP       
AP010/14/1980SCS       
AP07/17/1981SCM       
AP03/26/1981SLR       
AP03/4/1983SCE       
AP05/11/1982SCS       
AP08/11/1982SCS       
AP010/18/1982SCP       
AP010/18/1982SCP       
AP010/18/1982SCP       
AP010/18/1982SLR       
AP011/30/1982SCP       
AP012/10/1982SCP       
AP01/20/1983SCS       
AP01/20/1983SCS       
AP01/13/1984SLR       
AP01/13/1984SCS       
AP04/16/1985SCM       
AP08/27/1986SCE       
AP01/20/1988SCS       
AP02/7/2002SLR9607072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf 6/29/2004
AP02/7/2002SLR17100072   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013263_S072_VALIUM_AP.pdf 7/6/2007
AP011/8/1988SCM       
AP010/26/1989SCM       
AP02/7/2002SLR17094075   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013263_S075_VALIUM_AP.pdf 7/6/2007
AP02/7/2002SLR2090075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf 2/7/2002
AP09/5/1997SCS       
AP011/5/1997SCM       
AP09/19/1997SCP       
AP09/4/1998SCS       
AP05/12/2008SLR19823080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013263s080,s083ltr.pdf 5/14/2008
AP08/30/2000SCM17095081   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/016087_S081_VALIUM_AP.pdf 7/6/2007
AP05/9/2001SCM15224082   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/013263_S082_Valium_APPROVAL PACKAGE.pdf 10/25/2006
AP05/9/2001SCM2098082   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/13263s82ltr.pdf 5/9/2001
AP05/12/2008SLR19824083   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013263s080,s083ltr.pdf 5/14/2008
AP05/12/2008SLR19940083   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013263s083lbl.pdf 6/5/2008
AP010/25/2001SCM       
AP011/8/2001SCP       
AP02/12/2002SCS2095086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/13263s86ltr.pdf 2/12/2002
AP02/12/2002SCS17139086   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013263_S086_VALIUM_AP.pdf 7/9/2007
AP04/19/2013SCM       
AP010/22/2013SLR37539092   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/013263Orig1s092ltr.pdf 10/24/2013
AP010/22/2013SLR37588092   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/013263s092lbl.pdf 10/25/2013
AP07/30/2015SCM       




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