APPLICATION
NDA009321
TYPE
NDA
ORIGINAL APPROVAL
1954-04-27
LATEST ACTION
2017-04-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CHOLOGRAFIN MEGLUMINEDiscontinued
IODIPAMIDE MEGLUMINE 10.3% · INJECTABLE · INJECTION
CHOLOGRAFIN MEGLUMINE · ReferenceDiscontinued
IODIPAMIDE MEGLUMINE 52% · INJECTABLE · INJECTION
CHOLOGRAFIN SODIUMDiscontinued
IODIPAMIDE SODIUM 20% · INJECTABLE · INJECTION
Approval history
2000-03-16Manufacturing (CMC) · Supplement 24 · standardAP
1995-05-11Labeling · Supplement 23 · standardAP
1994-04-29Manufacturing (CMC) · Supplement 22 · standardAP
1985-08-06Manufacturing (CMC) · Supplement 21 · standardAP
1982-04-12Labeling · Supplement 18AP
1979-10-01Labeling · Supplement 17AP
1977-07-05Manufacturing (CMC) · Supplement 15 · standardAP
1977-05-16Manufacturing (CMC) · Supplement 16 · standardAP
1976-12-02Labeling · Supplement 14AP
1954-04-27Type 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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