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FDA NDA · NDA008032

TELEPAQUE

Sponsor: GE HEALTHCARE

APPLICATION
NDA008032
TYPE
NDA
ORIGINAL APPROVAL
1951-07-16
LATEST ACTION
1990-05-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TELEPAQUEDiscontinued
IOPANOIC ACID 500MG · TABLET · ORAL

Approval history

1990-05-02Manufacturing (CMC) · Supplement 23 · priorityAP
1987-05-20Manufacturing (CMC) · Supplement 22 · priorityAP
1986-07-01Labeling · Supplement 21 · priorityAP
1985-11-23Labeling · Supplement 20 · priorityAP
1985-04-19Labeling · Supplement 19 · priorityAP
1984-03-14Labeling · Supplement 18 · priorityAP
1983-09-30Manufacturing (CMC) · Supplement 17 · priorityAP
1979-11-27Labeling · Supplement 15 · priorityAP
1978-10-12Labeling · Supplement 13 · priorityAP
1976-10-18Labeling · Supplement 9 · priorityAP
1976-10-15Labeling · Supplement 11 · priorityAP
1976-10-15Manufacturing (CMC) · Supplement 12 · priorityAP
1976-10-15Labeling · Supplement 10 · priorityAP
1951-07-16Type 1 - New Molecular Entity · Original · priorityAP
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