FDA.reportPublic FDA data

Application 022161

Type
NDA
Sponsor
ASTELLAS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEXISCANREGADENOSONSOLUTION;INTRAVENOUS0.4MG/5ML (0.08MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0469-6501LEXISCANregadenosonAstellas Pharma US, Inc.NDACurrent
51662-1448LEXISCAN(R) (REGADENOSON)LEXISCAN(R) (REGADENOSON)HF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1448LEXISCAN(R) (REGADENOSON)LEXISCAN(R) (REGADENOSON)HF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1448LEXISCAN(R) (REGADENOSON)LEXISCAN(R) (REGADENOSON)HF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54405SUPPL2018-06-01
54400SUPPL2018-05-31
46905SUPPL2017-01-19
46881SUPPL2017-01-17
29345SUPPL2014-09-23
38326SUPPL2014-09-22
23699ORIG2014-02-07
29344SUPPL2014-01-14
17038SUPPL2014-01-10
38325SUPPL2014-01-07
6993SUPPL2014-01-07
6992SUPPL2011-10-04
17037SUPPL2011-09-30
38324SUPPL2011-09-29
38323SUPPL2011-09-29
17036SUPPL2011-09-29
29343SUPPL2011-09-28
29342SUPPL2011-09-28
6991SUPPL2011-09-28
6990SUPPL2009-12-31
38322SUPPL2009-12-30
38321SUPPL2009-04-03
6989SUPPL2009-03-19
21950ORIG2008-06-02
29341ORIG2008-04-16
17035ORIG2008-04-16