← FDA DRUG APPROVALS

FDA NDA · NDA203971

XOFIGO

radium ra 223 dichloride

Sponsor: BAYER HLTHCARE

APPLICATION
NDA203971
TYPE
NDA
ORIGINAL APPROVAL
2013-05-15
LATEST ACTION
2019-12-10
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

XOFIGO · ReferencePrescription
RADIUM RA-223 DICHLORIDE 162mCi/6ML (27mCi/ML) · SOLUTION · INTRAVENOUS

Approval history

2019-12-10Labeling · Supplement 16 · standard — Letter ↗AP
2018-08-31Labeling · Supplement 14 · standard — Label ↗AP
2018-02-02Labeling · Supplement 12 · standard — Label ↗AP
2016-05-12Manufacturing (CMC) · Supplement 10 · priorityAP
2016-04-29Manufacturing (CMC) · Supplement 9 · priorityAP
2016-03-18Labeling · Supplement 7 · standard — Letter ↗AP
2016-01-22Manufacturing (CMC) · Supplement 8 · priorityAP
2015-09-10Manufacturing (CMC) · Supplement 6 · priorityAP
2015-05-12Manufacturing (CMC) · Supplement 5 · priorityAP
2015-02-16Manufacturing (CMC) · Supplement 1 · priorityAP
2013-05-15Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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