Back to FDA Applications sponsored by LILLY

FDA Drug Application 021368 by LILLY

Application Number021368
Application Type New Drug Application
Sponsor ApplicantLILLY
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/21/2003N6919000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021368lbl.pdf 11/21/2003
AP011/21/2003N6920000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021368ppilbl.pdf 11/21/2003
AP011/21/2003N6921000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21368ltr.pdf 11/21/2003
AP011/21/2003N7834000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-368_Cialis.cfm 3/8/2004
AP011/21/2003N12340000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118686.htm 7/28/2005
AP03/31/2005SLR11348004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021368s004,005ltr.pdf 4/6/2005
AP03/31/2005SLR11352004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021368s004,005lbl.pdf 4/6/2005
AP03/31/2005SLR11349005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021368s004,005ltr.pdf 4/6/2005
AP03/31/2005SLR11351005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021368s004,005lbl.pdf 4/6/2005
AP07/8/2005SLR11967006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021368s006lbl.pdf 7/8/2005
AP07/8/2005SLR12003006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021368s006ltr.pdf 7/15/2005
AP01/22/2007SLR15696007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021368s007lbl.pdf 1/24/2007
AP01/22/2007SLR15705007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021368s007ltr.pdf 1/25/2007
AP03/7/2006SLR13740008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s008lbl.pdf 3/10/2006
AP03/7/2006SLR13826008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021368s008ltr.pdf 3/23/2006
AP010/23/2006SLR15204009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s009,s010lbl.pdf 10/25/2006
AP010/23/2006SLR15252009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021368s009, s010ltr.pdf 10/26/2006
AP010/23/2006SLR15205010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021368s009,s010lbl.pdf 10/25/2006
AP010/23/2006SLR15253010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021368s009, s010ltr.pdf 10/26/2006
AP01/7/2008SE218740011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021368s011lbl.pdf 1/8/2008
AP01/7/2008SE218805011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021368s011ltr.pdf 1/9/2008
AP010/18/2007SLR18247012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021368s012lbl.pdf 10/18/2007
AP010/18/2007SLR18272012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021368s012ltr.pdf 10/22/2007
AP08/7/2008SLR20606013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021368s013ltr.pdf 8/13/2008
AP02/1/2010SLR24758017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021368s017lbl.pdf 2/16/2010
AP02/1/2010SLR24785017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021368s017ltr.pdf 2/16/2010
AP010/6/2011SE130226020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021368s20s21lbl.pdf 10/7/2011
AP010/6/2011SE130245020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021368s020,s021ltr.pdf 10/12/2011
AP010/6/2011SE138304020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021368Orig1s020.pdf 1/17/2014
AP010/6/2011SE130227021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021368s20s21lbl.pdf 10/7/2011
AP010/6/2011SE130246021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021368s020,s021ltr.pdf 10/12/2011
AP010/10/2013SE837413022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021368Orig1s022ltr.pdf 10/11/2013
AP010/10/2013SE837439022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021368s022lbl.pdf 10/17/2013
AP04/29/2014SLR39183023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021368Orig1s023ltr.pdf 4/30/2014
AP04/29/2014SLR39208023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021368s023lbl.pdf 5/2/2014
AP09/1/2015SCM       
AP09/16/2015SLR43909026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021368Orig1s026ltr.pdf 9/17/2015
AP09/16/2015SLR43965026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021368s026lbl.pdf 9/23/2015
AP04/22/2016SLR45748027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021368Orig1s027ltr.pdf 4/26/2016
AP04/22/2016SLR45800027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021368s027lbl.pdf 4/29/2016
AP07/12/2016SCM       




Back to FDA Applications sponsored by LILLY