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FDA Drug Application 020628 by HOFFMANN LA ROCHE

Application Number020628
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
AP012/6/1995N26662000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM229206.pdf 10/13/2010
AP06/26/1996SLR       
AP010/3/1996SCE       
AP09/27/1996SE7       
AP07/31/1996SCM       
AP02/27/1997SLR4292007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20628ap_s007.pdf 2/27/1997
AP09/24/1997SCS       
AP01/16/1998SLR       
AP09/9/1998SCM       
AP03/16/1999SCS       
AP03/18/1999SCM       
AP09/8/1999SCS       
AP011/14/2000SLR       
AP05/11/2000SCM18101015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020628_S015_Invirase.pdf 9/26/2007
AP07/2/2002SLR1917016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20628s016ltr.pdf 6/24/2002
AP07/2/2002SLR1918016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20628s16lbl.pdf 6/24/2002
AP07/2/2002SLR11470016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-628s016_Invirase.cfm 4/27/2005
AP012/24/2003SE27511020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20628se2-020ltr.pdf 1/14/2004
AP012/24/2003SE27550020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20628se2-020_Invirase_lbl.pdf 1/15/2004
AP012/24/2003SE27675020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20628s020ppi.pdf 2/3/2004
AP012/24/2003SE218534020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020628_S020_INVIRASE.pdf 11/19/2007
AP09/8/2005SLR12765022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021785s001,002,020828s019,020,020628s022,023ltr.pdf 9/14/2005
AP09/8/2005SLR13026022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,s020,020628s022,s023ppi.pdf 11/4/2005
AP09/8/2005SLR12772022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf 9/14/2005
AP09/8/2005SLR12773023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,020,020628s022,023lbl.pdf 9/14/2005
AP09/8/2005SLR17506023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020628_S023_FORTOVASE.pdf 8/6/2007
AP09/8/2005SLR13027023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021785s001,002,020828s019,s020,020628s022,s023ppi.pdf 11/4/2005
AP09/8/2005SLR12766023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021785s001,002,020828s019,020,020628s022,023ltr.pdf 9/14/2005
AP04/3/2007SLR16165024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020628s024,021785s003lbl.pdf 4/6/2007
AP04/3/2007SLR16173024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020628s024, 021785s003ltr.pdf 4/9/2007
AP07/11/2007SLR17280025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020628s025,021785s004ltr.pdf 7/16/2007
AP07/11/2007SLR17291025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020628s025,021785s004lbl.pdf 7/16/2007
AP01/21/2010SLR24593027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s027,021785s006lbl.pdf 1/24/2010
AP01/21/2010SLR24643027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020628s027,021785s006ltr.pdf 1/26/2010
AP04/27/2010SLR25383032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020628s032,021785s009ltr.pdf 4/29/2010
AP04/27/2010SLR25514032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s032,021785s009lbl.pdf 5/7/2010
AP010/6/2010SLR26623033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020628s033,021785s010lbl.pdf 10/12/2010
AP010/6/2010SLR26636033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020628s033,021785s010ltr.pdf 10/12/2010
AP011/30/2012S34524034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020628Orig1s034,021785Orig1s011ltr.pdf 12/4/2012
AP011/30/2012S34537034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020628s034-021785s011lbl.pdf 12/4/2012
AP05/26/2011SLR28992037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020628s037,021785s014ltr.pdf 5/31/2011
AP02/17/2012SLR31855038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020628s038,021785s015lbl.pdf 2/22/2012
AP02/17/2012SLR31897038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020628s038,021785s015ltr.pdf 2/27/2012
AP04/21/2015SLR42631039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020628Orig1s039,021785Orig1s016ltr.pdf 4/22/2015
AP04/21/2015SLR42671039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s039,021785s016lbl.pdf 4/28/2015
AP02/26/2016SLR45308041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020628Orig1s041,021785Orig1s017ltr.pdf 3/2/2016
AP02/26/2016SLR45363041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020628s041,021785s017lbl.pdf 3/3/2016
AP03/27/2015SLR42323042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020628Orig1s042,21785Orig1s018ltr.pdf 3/31/2015
AP03/27/2015SLR42397042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s042,021785s018lbl.pdf 4/2/2015
AP012/16/2015SLR44797043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020628Orig1s043,021785Orig1s019ltr.pdf 12/17/2015
AP012/16/2015SLR44806043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020628s43-021785s19lbl.pdf 12/17/2015
AP02/1/2016SCM       
AP09/15/2016SLR47093045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020628Orig1s045,021785Orig1s021ltr.pdf 9/20/2016
AP09/15/2016SLR47157045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020628s045,021785s021lbl.pdf 9/23/2016




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