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FDA NDA · NDA017903

RENOVUE-DIP

Sponsor: BRACCO

APPLICATION
NDA017903
TYPE
NDA
ORIGINAL APPROVAL
1978-07-25
LATEST ACTION
2009-03-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

RENOVUE-DIPDiscontinued
IODAMIDE MEGLUMINE 24% · INJECTABLE · INJECTION

Approval history

2009-03-13Labeling · Supplement 3AP
1995-05-11Labeling · Supplement 9 · standardAP
1994-03-21Manufacturing (CMC) · Supplement 8 · standardAP
1985-08-06Manufacturing (CMC) · Supplement 6 · standardAP
1985-07-23Labeling · Supplement 7AP
1983-02-22Manufacturing (CMC) · Supplement 5 · standardAP
1982-11-23Efficacy · Supplement 4AP
1980-07-25Labeling · Supplement 1AP
1980-01-22Manufacturing (CMC) · Supplement 2 · standardAP
1978-07-25Type 3 - New Dosage Form · Original · standardAP
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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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