APPLICATION
NDA012967
TYPE
NDA
ORIGINAL APPROVAL
1962-06-25
LATEST ACTION
1992-09-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
ORAGRAFIN SODIUMDiscontinued
IPODATE SODIUM 500MG · CAPSULE · ORAL
Approval history
1992-09-17Manufacturing (CMC) · Supplement 36 · priorityAP
1988-04-13Labeling · Supplement 35 · priorityAP
1986-09-25Manufacturing (CMC) · Supplement 33 · priorityAP
1985-10-25Manufacturing (CMC) · Supplement 32 · priorityAP
1985-03-29Manufacturing (CMC) · Supplement 31 · priorityAP
1982-06-30Manufacturing (CMC) · Supplement 29 · priorityAP
1982-02-10Manufacturing (CMC) · Supplement 26 · priorityAP
1980-01-18Manufacturing (CMC) · Supplement 24 · priorityAP
1980-01-18Manufacturing (CMC) · Supplement 25 · priorityAP
1979-09-13Labeling · Supplement 23 · priorityAP
1979-04-17Manufacturing (CMC) · Supplement 22 · priorityAP
1978-10-25Manufacturing (CMC) · Supplement 20 · priorityAP
1978-10-20Manufacturing (CMC) · Supplement 21 · priorityAP
1978-06-07Manufacturing (CMC) · Supplement 17 · priorityAP
1978-06-07Manufacturing (CMC) · Supplement 15 · priorityAP
1978-05-23Labeling · Supplement 18 · priorityAP
1977-11-01Manufacturing (CMC) · Supplement 16 · priorityAP
1976-05-11Labeling · Supplement 14 · priorityAP
1975-12-30Labeling · Supplement 12 · priorityAP
1975-12-30Labeling · Supplement 9 · priorityAP
1975-12-19Manufacturing (CMC) · Supplement 13 · priorityAP
1975-12-19Manufacturing (CMC) · Supplement 11 · priorityAP
1962-06-25Type 1 - New Molecular Entity · Original · priorityAP
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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