APPLICATION
NDA017902
TYPE
NDA
ORIGINAL APPROVAL
1978-07-25
LATEST ACTION
2009-03-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
RENOVUE-65Discontinued
IODAMIDE MEGLUMINE 65% · INJECTABLE · INJECTION
Approval history
2009-03-13Labeling · Supplement 3AP
1995-05-11Labeling · Supplement 8 · standardAP
1993-03-21Manufacturing (CMC) · Supplement 7 · standardAP
1985-08-06Manufacturing (CMC) · Supplement 6 · standardAP
1983-02-22Manufacturing (CMC) · Supplement 5 · standardAP
1983-01-26Efficacy · Supplement 4AP
1980-07-25Labeling · Supplement 1AP
1980-07-04Manufacturing (CMC) · Supplement 2 · standardAP
1978-07-25Type 2 - New Active Ingredient · 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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