FDA NDA · NDA017279

GLOFIL-125

sodium iothalamate i-125 injection

Sponsor: ISOTEX

APPLICATION

NDA017279

TYPE

NDA

ORIGINAL APPROVAL

1974-02-12

LATEST ACTION

2002-01-22

ROUTE

INTRAVENOUS, INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription

Products

GLOFIL-125Prescription

IOTHALAMATE SODIUM I-125 250-300uCi/ML · INJECTABLE · INJECTION

2002-01-22Labeling · Supplement 8 · standard — Letter ↗AP

1997-03-27Labeling · Supplement 7 · standardAP

1994-08-08Labeling · Supplement 5AP

1981-01-16Manufacturing (CMC) · Supplement 3 · standardAP

1976-02-04Labeling · Supplement 2AP

1974-02-12Type 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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