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FDA Drug Application 018662 by HOFFMANN LA ROCHE

Application Number018662
Application Type New Drug Application
Sponsor ApplicantHOFFMANN LA ROCHE
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
AP05/7/1982N12296000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094305.htm 7/28/2005
AP05/7/1982N24802000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085812.pdf 2/17/2010
AP05/7/1982N43199000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=24 7/2/2015
AP06/6/1986SLR       
AP06/30/1983SCM       
AP06/6/1986SLR       
AP08/9/1983SLR       
AP06/19/1985SCS       
AP02/28/1984SLR       
AP05/31/1984SCP       
AP06/6/1986SLR       
AP011/1/1984SCM       
AP011/27/1984SCS       
AP06/6/1986SE2       
AP04/30/1985SLR       
AP07/5/1985SLR       
AP06/6/1986SLR       
AP06/6/1986SLR       
AP02/26/1987SCP       
AP06/1/1987SLR       
AP06/3/1987SCS       
AP010/19/1987SLR       
AP01/7/1988SCE       
AP08/26/1988SLR       
AP011/16/1988SCP       
AP04/28/1989SCP       
AP04/4/1989SCM       
AP08/9/1989SCP       
AP04/16/1990SLR       
AP03/7/1991SLR       
AP010/16/1990SCP       
AP010/8/1991SCS       
AP01/13/1994SLR       
AP05/17/1995SLR       
AP04/30/1999SCP       
AP05/1/2000SLR16989038   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018662_S038_ACCUTANE_AP.pdf 7/6/2007
AP05/1/2000SLR1419038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/18662s38ltr.pdf 5/1/2000
AP05/1/2000SLR1426039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/18662s39ltr.pdf 5/1/2000
AP05/1/2000SLR1511040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/18662s40ltr.pdf 5/1/2000
AP012/31/2001SLR1636041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18662s41s45ltr.pdf 12/31/2001
AP012/31/2001SLR1637041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18662s41s45lbl.pdf 12/31/2001
AP01/11/2001SCS16988042   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018662_S042_ACCUTANE_AP.pdf 7/6/2007
AP05/2/2002SE81634043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18662s043ltr.pdf 5/2/2002
AP05/2/2002SE81635043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s043lbl.pdf 5/2/2002
AP010/30/2001SLR1632044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18662s44ltr.pdf 10/30/2001
AP010/30/2001SLR1633044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18662s44lbl.pdf 10/30/2001
AP012/31/2001SLR1638045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18662s41s45ltr.pdf 12/31/2001
AP012/31/2001SLR1639045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18662s41s45lbl.pdf 12/31/2001
AP02/15/2002SLR1630046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18662s046ltr.pdf 2/15/2002
AP02/15/2002SLR1631046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s046lbl.pdf 2/15/2002
AP04/12/2002SLR1628047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18662s47ltr.pdf 4/12/2002
AP04/12/2002SLR1629047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s47Pi.pdf 4/12/2002
AP08/27/2003SLR6579048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18662slr048,052ltr.pdf 8/27/2003
AP08/27/2003SLR6587048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18662slr048,052_accutane_lbl.pdf 8/29/2003
AP08/27/2003SLR16982048   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018662_S048_ACCUTANE_AP.pdf 7/6/2007
AP06/20/2002SLR1626051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18662s051LTR.pdf 6/20/2002
AP06/20/2002SLR1627051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s051lbl.pdf 6/20/2002
AP08/27/2003SLR6589052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18662slr048,052_accutane_lbl.pdf 8/29/2003
AP08/27/2003SLR8575052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18662slr048,052ltr.pdf 5/25/2004
AP08/27/2003SLR16981052   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/018662_S052_ACCUTANE_AP.pdf 7/6/2007
AP03/26/2004SCM16987053   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018662_S053_ACCUTANE_AP.pdf 7/6/2007
AP08/24/2004SLR16986054   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018662_S054_ACCUTANE_AP.pdf 7/6/2007
AP08/24/2004SLR10061054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18662s054ltr.pdf 8/25/2004
AP08/24/2004SLR10067054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18662s054lbl.pdf 8/25/2004
AP08/10/2005S16984055   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/018662_S055_ACCUTANE_AP.pdf 7/6/2007
AP08/12/2005SLR16985056   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/018662_S056_ACCUTANE_AP.pdf 7/6/2007
AP08/12/2005SLR12589056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018662s056lbl.pdf 8/12/2005
AP08/12/2005SLR12608056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018662s056ltr.pdf 8/15/2005
AP01/13/2006S16983057   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/018662_S057_ACCUTANE_AP.pdf 7/6/2007
AP010/3/2007SLR18206058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018662s058ltr.pdf 10/10/2007
AP010/3/2007SLR18228058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018662s058lbl.pdf 10/10/2007
AP011/19/2008SLR21256059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018662s059ltr.pdf 11/21/2008
AP011/19/2008SLR22728059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018662s059lbl.pdf 6/10/2009
AP02/1/2010SLR24699060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018662s060lbl.pdf 2/4/2010
AP02/1/2010SLR24734060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018662s060ltr.pdf 2/5/2010
AP010/22/2010SLR26767061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018662s061MedGuide.pdf 10/25/2010
AP010/22/2010SLR26774061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018662s061ltr.pdf 10/26/2010




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