FDA NDA · NDA018058

GALLIUM CITRATE GA-67

Sponsor: CURIUM

APPLICATION

NDA018058

TYPE

NDA

ORIGINAL APPROVAL

1979-02-01

LATEST ACTION

2014-03-19

ROUTE

INTRAVENOUS, INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription

Products

GALLIUM CITRATE GA 67Prescription

GALLIUM CITRATE GA-67 2mCi/ML · INJECTABLE · INJECTION

2014-03-19Manufacturing (CMC) · Supplement 13 · standardAP

1985-11-22Manufacturing (CMC) · Supplement 10 · standardAP

1984-03-08Labeling · Supplement 5AP

1982-09-27Labeling · Supplement 7AP

1982-09-14Labeling · Supplement 8AP

1982-05-07Manufacturing (CMC) · Supplement 4 · standardAP

1981-12-11Manufacturing (CMC) · Supplement 3 · standardAP

1980-07-04Manufacturing (CMC) · Supplement 2 · standardAP

1980-07-04Manufacturing (CMC) · Supplement 1 · standardAP

1979-02-01Type 5 - New Formulation or New Manufacturer · Original · standardAP

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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