FDA NDA · NDA022161

LEXISCAN

regadenoson

Sponsor: ASTELLAS

APPLICATION

NDA022161

TYPE

NDA

ORIGINAL APPROVAL

2008-04-10

LATEST ACTION

2018-05-31

ROUTE

INTRAVENOUS

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

LEXISCAN · ReferencePrescription

REGADENOSON 0.4MG/5ML (0.08MG/ML) · SOLUTION · INTRAVENOUS

2018-05-31Labeling · Supplement 15 · standard — Label ↗AP

2017-01-17Efficacy · Supplement 13 · standard — Label ↗AP

2014-09-19Labeling · Supplement 12 · standard — Label ↗AP

2014-03-29Manufacturing (CMC) · Supplement 5 · standardAP

2014-01-09Labeling · Supplement 11 · standard — Letter ↗AP

2011-09-30Labeling · Supplement 9 · unknown — Letter ↗AP

2011-09-23Labeling · Supplement 7 · unknown — Letter ↗AP

2011-09-23Labeling · Supplement 8 · unknown — Label ↗AP

2011-09-23Labeling · Supplement 6 · standard — Letter ↗AP

2009-12-23Labeling · Supplement 4 · unknown — Letter ↗AP

2009-03-17Labeling · Supplement 3 · standard — Letter ↗AP

2008-04-10Type 1 - New Molecular Entity · Original · standard — Label ↗AP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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