Application 019937

Type
NDA
Sponsor
ASTELLAS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002ADENOCARDADENOSINEINJECTABLE;INJECTION3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0469-8234AdenocardadenosineAstellas Pharma US, Inc.NDACurrent
0469-8234AdenocardadenosineAstellas Pharma US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
19849SUPPL2010-01-07
11854SUPPL2009-11-19
19848SUPPL2005-07-21