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FDA Drug Application 021785 by HOFFMANN-LA ROCHE

Application Number021785
Application Type New Drug Application
Sponsor ApplicantHOFFMANN-LA ROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/17/2004N10877000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021785ltr.pdf 12/30/2004
AP012/17/2004N10900000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021785lbl.pdf 12/30/2004
AP012/17/2004N15004000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021785s000_InviraseTOC.cfm 9/27/2006
AP012/17/2004N26664000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229206.pdf 10/13/2010
AP09/8/2005SLR12767001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021785s001,002,020828s019,020,020628s022,023ltr.pdf 9/14/2005
AP09/8/2005SLR12776001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf 9/14/2005
AP09/8/2005SLR13024001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,s020,020628s022,s023ppi.pdf 11/4/2005
AP09/8/2005SLR12768002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021785s001,002,020828s019,020,020628s022,023ltr.pdf 9/14/2005
AP09/8/2005SLR12777002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf 9/14/2005
AP09/8/2005SLR13025002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,s020,020628s022,s023ppi.pdf 11/4/2005
AP09/8/2005SLR17400002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021785_S002_FORTOVASE.pdf 7/27/2007
AP04/3/2007SLR16164003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020628s024,021785s003lbl.pdf 4/6/2007
AP04/3/2007SLR16172003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020628s024, 021785s003ltr.pdf 4/9/2007
AP07/11/2007SLR17279004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020628s025,021785s004ltr.pdf 7/16/2007
AP07/11/2007SLR17290004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020628s025,021785s004lbl.pdf 7/16/2007
AP01/21/2010SLR24592006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s027,021785s006lbl.pdf 1/24/2010
AP01/21/2010SLR24644006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020628s027,021785s006ltr.pdf 1/26/2010
AP04/27/2010SLR25382009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020628s032,021785s009ltr.pdf 4/29/2010
AP04/27/2010SLR25513009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s032,021785s009lbl.pdf 5/7/2010
AP010/6/2010SLR26622010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s033,021785s010lbl.pdf 10/12/2010
AP010/6/2010SLR26637010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020628s033,021785s010ltr.pdf 10/12/2010
AP011/30/2012S34523011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020628Orig1s034,021785Orig1s011ltr.pdf 12/4/2012
AP011/30/2012S34534011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020628s034-021785s011lbl.pdf 12/4/2012
AP05/26/2011SLR28993014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020628s037,021785s014ltr.pdf 5/31/2011
AP02/17/2012SLR31854015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020628s038,021785s015lbl.pdf 2/22/2012
AP02/17/2012SLR31898015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020628s038,021785s015ltr.pdf 2/27/2012
AP04/21/2015SLR42632016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020628Orig1s039,021785Orig1s016ltr.pdf 4/22/2015
AP04/21/2015SLR42670016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s039,021785s016lbl.pdf 4/28/2015
AP02/26/2016SLR45309017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020628Orig1s041,021785Orig1s017ltr.pdf 3/2/2016
AP02/26/2016SLR45362017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020628s041,021785s017lbl.pdf 3/3/2016
AP03/27/2015SLR42324018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020628Orig1s042,21785Orig1s018ltr.pdf 3/31/2015
AP03/27/2015SLR42396018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s042,021785s018lbl.pdf 4/2/2015
AP012/16/2015SLR44798019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020628Orig1s043,021785Orig1s019ltr.pdf 12/17/2015
AP012/16/2015SLR44807019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s43-021785s19lbl.pdf 12/17/2015
AP09/15/2016SLR47094021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020628Orig1s045,021785Orig1s021ltr.pdf 9/20/2016
AP09/15/2016SLR47156021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020628s045,021785s021lbl.pdf 9/23/2016




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