FDA.reportPublic FDA data

Application 022307

Type
NDA
Sponsor
ELI LILLY AND CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EFFIENTPRASUGREL HYDROCHLORIDETABLET;ORALEQ 5MG BASEYesNo
002EFFIENTPRASUGREL HYDROCHLORIDETABLET;ORALEQ 10MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-5121EffientPrasugrel hydrochlorideEli Lilly and CompanyNDACurrent
0002-5121EffientPrasugrel hydrochlorideEli Lilly and CompanyNDACurrent
0002-5121EffientPrasugrel hydrochlorideEli Lilly and CompanyNDACurrent
0002-5121EffientPrasugrel hydrochlorideEli Lilly and CompanyNDACurrent
0002-5121EffientPrasugrel hydrochlorideEli Lilly and CompanyNDACurrent
0002-5121EffientPrasugrel hydrochlorideEli Lilly and CompanyNDACurrent
0002-5121EffientPrasugrel hydrochlorideEli Lilly and CompanyNDACurrent
0002-5123EffientPrasugrel hydrochlorideEli Lilly and CompanyNDACurrent
0002-5123EffientPrasugrel hydrochlorideEli Lilly and CompanyNDACurrent
0002-5123EffientPrasugrel hydrochlorideEli Lilly and CompanyNDACurrent
0002-5123EffientPrasugrel hydrochlorideEli Lilly and CompanyNDACurrent
0002-5123EffientPrasugrel hydrochlorideEli Lilly and CompanyNDACurrent
0002-5123EffientPrasugrel hydrochlorideEli Lilly and CompanyNDACurrent
0002-5123EffientPrasugrel hydrochlorideEli Lilly and CompanyNDACurrent
0713-0881EffientPrasugrel HydrochlorideCosette Pharmaceuticals, Inc.NDACurrent
0713-0881EffientPrasugrel HydrochlorideCosette Pharmaceuticals, Inc.NDACurrent
0713-0882EffientPrasugrel HydrochlorideCosette Pharmaceuticals, Inc.NDACurrent
0713-0882EffientPrasugrel HydrochlorideCosette Pharmaceuticals, Inc.NDACurrent
65597-601EffientPrasugrel HydrochlorideDaiichi Sankyo, Inc.NDACurrent
65597-601EffientPrasugrel HydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-601EffientPrasugrel HydrochlorideDaiichi Sankyo, Inc.NDACurrent
65597-602EffientPrasugrel HydrochlorideDaiichi Sankyo, Inc.NDACurrent
65597-602EffientPrasugrel HydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-602EffientPrasugrel HydrochlorideDaiichi Sankyo, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65752SUPPL2020-12-28
65751SUPPL2020-12-28
65716SUPPL2020-12-23
58177SUPPL2019-04-02
58176SUPPL2019-04-02
58152SUPPL2019-03-29
56343SUPPL2018-11-08
52995SUPPL2018-03-15
52923SUPPL2018-03-13
24024SUPPL2016-07-29
38545SUPPL2016-07-13
29566SUPPL2016-07-13
38544SUPPL2016-02-23
42485SUPPL2016-02-10
29565SUPPL2016-01-15
29564SUPPL2015-07-10
38543SUPPL2015-07-09
44181ORIG2014-12-23
38542SUPPL2013-11-22
7210SUPPL2013-11-20
38541SUPPL2013-10-18
29563SUPPL2013-10-17
43849ORIG2012-12-05
29562SUPPL2012-12-04
17221SUPPL2012-12-04
29561SUPPL2012-03-27
38540SUPPL2011-09-30
7209SUPPL2011-09-29
7208SUPPL2010-12-10
17220SUPPL2010-12-06
38539SUPPL2010-05-03
29560SUPPL2010-04-22
44733ORIG2009-07-13
42484ORIG2009-07-13
29559ORIG2009-07-13
17219ORIG2009-07-13
64051ORIG1900-01-01
64050ORIG1900-01-01
58113ORIG1900-01-01
51582ORIG1900-01-01
51580ORIG1900-01-01
51579ORIG1900-01-01