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FDA Drug Application 021366 by IPR

Application Number021366
Application Type New Drug Application
Sponsor ApplicantIPR
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/12/2003N6489000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21366_crestor_lbl.pdf 8/14/2003
AP08/12/2003N7572000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21366ltr.pdf 1/20/2004
AP08/12/2003N7630000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-366_Crestor.cfm 1/29/2004
AP08/12/2003N8026000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109095.htm 3/24/2004
AP03/2/2005SLR11182005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21366slr005lbl.pdf 3/2/2005
AP03/2/2005SLR11190005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21366s005ltr.pdf 3/3/2005
AP011/8/2007SE118412010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021366s010lbl.pdf 11/13/2007
AP011/8/2007SE118465010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021366s010ltr.pdf 11/19/2007
AP011/8/2007SE130059010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021366s010.pdf 9/22/2011
AP011/8/2007SE130805010NDA Review  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021366Orig1s010.pdf 11/1/2011
AP011/8/2007SE131010010Approval Package  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021366Orig1s010.pdf 12/16/2011
AP07/23/2007SLR17361011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021366s011lbl.pdf 7/24/2007
AP07/23/2007SLR17386011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021366s011ltr.pdf 7/27/2007
AP011/6/2008SE121174013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021366s013lbl.pdf 11/7/2008
AP011/6/2008SE121226013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021366s013ltr.pdf 11/13/2008
AP01/23/2009SLR21677014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021366s014ltr.pdf 1/26/2009
AP01/23/2009SLR21684014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021366s014lbl.pdf 1/29/2009
AP03/27/2009SLR22147015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021366s015ltr.pdf 4/1/2009
AP03/27/2009SLR22174015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021366s015lbl.pdf 4/3/2009
AP02/8/2010SE124745016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021366s016lbl.pdf 2/8/2010
AP02/8/2010SE124746016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021366s016ltr.pdf 2/12/2010
AP02/8/2010SE126022016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021366s016_crestor_toc.cfm 7/27/2010
AP02/8/2010SE126023016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021366s016SumR.pdf 7/27/2010
AP010/15/2009SE523662017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021366s017lbl.pdf 10/21/2009
AP010/15/2009SE524139017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021366s017ltr.pdf 11/25/2009
AP01/22/2010SLR24598018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021366s018lbl.pdf 1/24/2010
AP01/22/2010SLR24658018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021366s018ltr.pdf 1/28/2010
AP011/19/2010SLR27013021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021366s021ltr.pdf 11/26/2010
AP011/19/2010SLR27017021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021366s021lbl.pdf 11/26/2010
AP02/28/2012SLR31936024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021366Orig1s024ltr.pdf 2/28/2012
AP02/28/2012SLR31951024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021366Orig1s024Lbl.pdf 2/28/2012
AP02/28/2012SLR31952024Tracked Changes Label  http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021366Orig1s024Lbl-TrackedchangesLBL.pdf 2/28/2012
AP02/28/2012SLR32300024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021366s024.pdf 3/30/2012
AP010/31/2012SLR34234025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021366s025s027lbl.pdf 11/2/2012
AP010/31/2012SLR34257025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021366Orig1s025,s027ltr.pdf 11/5/2012
AP012/20/2012SLR34741026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021366s026lbl.pdf 12/21/2012
AP012/20/2012SLR34757026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021366Orig1s026ltr.pdf 12/26/2012
AP010/31/2012SLR34258027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021366Orig1s025,s027ltr.pdf 11/5/2012
AP010/31/2012SLR34235027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021366s025s027lbl.pdf 11/2/2012
AP08/7/2013SLR36723028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021366Orig1s028,s029ltr.pdf 8/8/2013
AP08/7/2013SLR36766028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021366s028s029lbl.pdf 8/9/2013
AP08/7/2013SLR36767029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021366s028s029lbl.pdf 8/9/2013
AP08/7/2013SLR36722029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021366Orig1s028,s029ltr.pdf 8/8/2013
AP07/8/2014SLR39825030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021366Orig1s030ltr.pdf 7/10/2014
AP07/8/2014SLR40205030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021366s030lbl.pdf 8/12/2014
AP011/20/2015SE844566031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021366Orig1s031ltr.pdf 11/23/2015
AP011/20/2015SE844589031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021366s031lbl.pdf 11/25/2015
AP06/1/2015SLR42975032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021366Orig1s032ltr.pdf 6/4/2015
AP06/1/2015SLR42984032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021366s032lbl.pdf 6/4/2015
AP05/27/2016SE846189033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021366Orig1s033ltr.pdf 5/31/2016
AP05/27/2016SE846227033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021366s033lbl.pdf 6/1/2016
AP010/14/2016SCM       




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