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FDA Drug Application 021858 by ROCHE

Application Number021858
Application Type New Drug Application
Sponsor ApplicantROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/6/2006N13376000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021858s000ltr.pdf 1/10/2006
AP01/6/2006N13377000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021858s000lbl.pdf 1/10/2006
AP01/6/2006N16461000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021858s000TOC.cfm 5/9/2007
AP01/6/2006N18700000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm 1/7/2008
AP01/6/2006N36005000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241455.pdf 5/9/2013
AP08/7/2006SLR14638001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021858s001lbl.pdf 8/9/2006
AP08/7/2006SLR14653001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021858s001LTR.pdf 8/9/2006
AP02/12/2007SLR15883004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021858s004ltr.pdf 2/23/2007
AP04/19/2013SLR35798008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021858s008s013s014lbl.pdf 4/23/2013
AP04/19/2013SLR35816008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021858Orig1s008,s013,s014ltr.pdf 4/24/2013
AP01/25/2011SLR27611009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021858s009MedG.pdf 1/26/2011
AP01/25/2011SLR27612009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021858s009lbl.pdf 1/26/2011
AP01/25/2011SLR27616009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021858s009ltr.pdf 1/27/2011
AP08/10/2011SLR29751010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021858s010ltr.pdf 8/12/2011
AP07/1/2011SLR29437012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021858s012ltr.pdf 7/7/2011
AP04/19/2013SLR35817013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021858Orig1s008,s013,s014ltr.pdf 4/24/2013
AP04/19/2013SLR35799013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021858s008s013s014lbl.pdf 4/23/2013
AP04/19/2013SLR35800014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021858s008s013s014lbl.pdf 4/23/2013
AP04/19/2013SLR35818014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021858Orig1s008,s013,s014ltr.pdf 4/24/2013
AP06/18/2014SCM       
AP010/20/2014SCM       
AP09/8/2014SCM       
AP05/4/2015SCM       
AP03/18/2015SLR42205019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021858s019lbl.pdf 3/19/2015
AP03/18/2015SLR42209019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021858Orig1s019ltr.pdf 3/19/2015
AP04/8/2015SLR42484020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021858s020lbl.pdf 4/10/2015
AP04/8/2015SLR42507020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021858Orig1s020ltr.pdf 4/13/2015
AP07/22/2015SCM       




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