APPLICATION
NDA017685
TYPE
NDA
ORIGINAL APPROVAL
1976-09-07
LATEST ACTION
2009-03-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CONRAY 325Discontinued
IOTHALAMATE SODIUM 54.3% · INJECTABLE · INJECTION
Approval history
2009-03-13Labeling · Supplement 3AP
2009-03-13Labeling · Supplement 5AP
1995-01-13Labeling · Supplement 15 · standardAP
1992-12-04Manufacturing (CMC) · Supplement 13 · standardAP
1992-08-28Manufacturing (CMC) · Supplement 11 · standardAP
1992-08-28Manufacturing (CMC) · Supplement 14 · standardAP
1990-03-30Manufacturing (CMC) · Supplement 12 · standardAP
1989-12-01Manufacturing (CMC) · Supplement 10 · standardAP
1989-10-10Manufacturing (CMC) · Supplement 9 · standardAP
1985-03-05Labeling · Supplement 8AP
1984-12-04Manufacturing (CMC) · Supplement 7 · standardAP
1984-06-25Manufacturing (CMC) · Supplement 6 · standardAP
1981-08-24Manufacturing (CMC) · Supplement 4 · standardAP
1979-02-22Labeling · Supplement 1AP
1978-09-06Manufacturing (CMC) · Supplement 2 · standardAP
1976-09-07Type 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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