APPLICATION
NDA016666
TYPE
NDA
ORIGINAL APPROVAL
1968-05-24
LATEST ACTION
1998-05-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HIPPURAN I 131Discontinued
IODOHIPPURATE SODIUM I-131 0.25mCi/ML · INJECTABLE · INJECTION
Approval history
1998-05-15Manufacturing (CMC) · Supplement 15 · standardAP
1982-08-16Labeling · Supplement 12 · standardAP
1982-05-07Manufacturing (CMC) · Supplement 13 · standardAP
1978-04-07Manufacturing (CMC) · Supplement 10 · standardAP
1977-08-23Manufacturing (CMC) · Supplement 9 · standardAP
1977-07-27Manufacturing (CMC) · Supplement 8 · standardAP
1975-12-19Labeling · Supplement 6 · standardAP
1968-05-24Type 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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