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FDA Drug Application 050585 by HOFFMANN LA ROCHE

Application Number050585
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
AP012/21/1984N17818000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandhttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm10Providers/ucm109103.htm 9/11/2007
AP05/10/1985SLR       
AP011/22/1991SE2       
AP010/7/1986SCG       
AP010/7/1986SCG       
AP09/25/1989SLR       
AP03/11/1991SLR       
AP08/26/1988SCG       
AP02/7/1989SCG       
AP06/29/1989SCG       
AP02/11/1992SE1       
AP03/11/1991SCG       
AP03/11/1991SLR       
AP012/31/1990SE1       
AP02/4/1992SCM       
AP01/31/1992SCS       
AP09/12/1991SCM       
AP010/7/1993SLR       
AP05/28/1993SE2       
AP06/17/1992SE1       
AP09/23/1992SCS       
AP03/14/1996SCM       
AP04/26/1994SLR       
AP02/8/1993SCM       
AP02/4/1994SCM       
AP08/18/1994SLR       
AP05/8/1996SE2       
AP09/14/1995SLR       
AP012/23/1997SE2       
AP08/25/2000SLR       
AP04/28/1998SCS       
AP010/18/1999SCS       
AP08/18/2008SLR20685050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050585s050s060lbl.pdf 8/26/2008
AP03/29/2004SLR8217054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50585slr054_rocephin_lbl.pdf 4/5/2004
AP03/29/2004SLR8297054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50585slr054ltr.pdf 4/7/2004
AP09/2/2004SLR10109056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50585s056,50624s026lbl.pdf 9/3/2004
AP09/2/2004SLR10116056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50585s056,50624s026ltr.pdf 9/3/2004
AP09/14/2004S10191057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50585s057,50624s027ltr.pdf 9/15/2004
AP09/14/2004S10192057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50585s057,50624s027lbl.pdf 9/15/2004
AP07/17/2007SLR17338058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050585s058ltr.pdf 7/24/2007
AP07/17/2007SLR17357058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050585s058lbl.pdf 7/24/2007
AP05/11/2007SLR16562059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050585s059ltr.pdf 5/16/2007
AP05/11/2007SLR16571059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050585s059lbl.pdf 5/16/2007
AP08/18/2008SLR20686060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050585s050s060lbl.pdf 8/26/2008
AP08/18/2008SLR20652060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050585s050,050585s060ltr.pdf 8/20/2008
AP03/11/2009SLR21998061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050585s061ltr.pdf 3/13/2009
AP03/11/2009SLR22191061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050585s061lbl.pdf 4/3/2009
AP011/12/2010SLR26966062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050585s062lbl.pdf 11/17/2010
AP011/12/2010SLR26980062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050585s062ltr.pdf 11/18/2010
AP06/7/2009SLR22733063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/0550585s063lbl.pdf 6/10/2009
AP06/7/2009SLR22754063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050585s063ltr.pdf 6/16/2009
AP02/25/2010SLR24926064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050585s064lbl.pdf 3/3/2010
AP02/25/2010SLR24956064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050585s064ltr.pdf 3/4/2010
AP04/12/2013SLR35702065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050585Orig1s065ltr.pdf 4/16/2013
AP04/12/2013SLR35723065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050585s065lbl.pdf 4/16/2013
AP03/20/2015SLR42235066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050585s066lbl.pdf 3/23/2015
AP03/20/2015SLR42238066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050585Orig1s066ltr.pdf 3/24/2015
AP06/30/2015SLR43175067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050585s067lbl.pdf 7/1/2015
AP06/30/2015SLR43272067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050585Orig1s067ltr.pdf 7/8/2015




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