Back to FDA Applications sponsored by ROCHE

FDA Drug Application 017533 by ROCHE

Application Number017533
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/4/1975N37750000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM225680.pdf 11/8/2013
AP09/26/1975SCS       
AP06/30/1975SLR       
AP08/30/1978SLR       
AP03/23/1979SCP       
AP09/19/1979SCS       
AP02/24/1981SCM       
AP06/13/1980SCP       
AP01/13/1981SCS       
AP012/19/1983SCP       
AP012/11/1984SCS       
AP012/13/1985SLR       
AP05/1/1987SCS       
AP07/19/1990SCE       
AP07/19/1990SLR       
AP04/30/1993SLR       
AP05/28/1993SCM       
AP04/30/1993SLR       
AP06/3/1993SCS       
AP06/3/1993SCS       
AP07/1/1994SCS       
AP04/9/1997SE1       
AP06/18/1996SCS       
AP08/30/1996SCM       
AP010/17/1996SCM       
AP011/20/1996SCM       
AP03/7/1997SCE       
AP09/19/1997SCP       
AP012/30/1997SCP       
AP04/11/2001SLR1996031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17533S31ltr.pdf 1/22/2001
AP04/11/2001SLR16204031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/017533_S031_KLONOPIN_TABS_AP.pdf 4/9/2007
AP010/18/1999SCM       
AP03/28/2000SCS       
AP01/22/2001SCM       
AP09/10/2001SCS       
AP011/7/2001SCP       
AP01/29/2002SLR1995037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17533s37ltr.pdf 1/29/2002
AP01/29/2002SLR16205037   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017533_S037_KLONOPIN_TABS_AP.pdf 4/9/2007
AP03/11/2002SCE       
AP03/15/2002SCE       
AP04/23/2009SLR22375045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017533s045,020813s005ltr.pdf 5/1/2009
AP04/23/2009SLR22528045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017533s045,020813s005lbl.pdf 5/12/2009
AP09/1/2010SLR32797046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007MedGuide.pdf 6/4/2012
AP09/1/2010SLR32798046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007lbl.pdf 6/4/2012
AP09/1/2010SLR32799046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017533s046,s048,020813s006,s007ltr.pdf 6/4/2012
AP09/1/2010SLR26402048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007MedGuide.pdf 9/7/2010
AP09/1/2010SLR26404048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017533s046s048,020813s006s007lbl.pdf 9/7/2010
AP09/1/2010SLR26520048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017533s046,s048,020813s006,s007ltr.pdf 9/21/2010
AP011/29/2011SLR30973052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017533s052,020813s008ltr.pdf 12/14/2011
AP010/31/2013SLR37672053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017533s053,020813s009lbl.pdf 11/1/2013
AP010/31/2013SLR37711053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017533Orig1s053,020813Orig1s009ltr.pdf 11/6/2013
AP02/3/2015SCM       
AP03/25/2016SLR45525055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017533s055lbl.pdf 3/29/2016
AP03/25/2016SLR45530055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017533Orig1s055ltr.pdf 3/29/2016
AP06/13/2016SCM       




Back to FDA Applications sponsored by ROCHE