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FDA NDA · NDA020134

METASTRON

Sponsor: Q BIOMED

APPLICATION
NDA020134
TYPE
NDA
ORIGINAL APPROVAL
1993-06-18
LATEST ACTION
2013-12-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

METASTRON · ReferencePrescription
STRONTIUM CHLORIDE SR-89 1mCi/ML · INJECTABLE · INJECTION

Approval history

2013-12-20Labeling · Supplement 12 · standard — Letter ↗AP
2013-04-03Manufacturing (CMC) · Supplement 10 · priorityAP
1999-08-24Manufacturing (CMC) · Supplement 7 · priorityAP
1997-10-10Manufacturing (CMC) · Supplement 2 · priorityAP
1997-01-07Manufacturing (CMC) · Supplement 5 · priorityAP
1996-08-30Manufacturing (CMC) · Supplement 6 · priorityAP
1995-12-20Manufacturing (CMC) · Supplement 4 · priorityAP
1993-06-18Type 1 - New Molecular Entity · Original · priorityAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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