APPLICATION
NDA016783
TYPE
NDA
ORIGINAL APPROVAL
1971-01-26
LATEST ACTION
2009-03-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
VASCORAYDiscontinued
IOTHALAMATE MEGLUMINE 52%, IOTHALAMATE SODIUM 26% · INJECTABLE · INJECTION
Approval history
2009-03-13Labeling · Supplement 13AP
2009-03-13Labeling · Supplement 16AP
1995-01-13Labeling · Supplement 29 · standardAP
1992-12-04Manufacturing (CMC) · Supplement 27 · standardAP
1992-08-28Manufacturing (CMC) · Supplement 28 · standardAP
1990-03-30Manufacturing (CMC) · Supplement 26 · standardAP
1989-12-01Manufacturing (CMC) · Supplement 24 · standardAP
1989-10-10Manufacturing (CMC) · Supplement 21 · standardAP
1989-06-28Labeling · Supplement 25AP
1988-08-19Manufacturing (CMC) · Supplement 23 · standardAP
1985-04-23Labeling · Supplement 22AP
1984-12-04Manufacturing (CMC) · Supplement 20 · standardAP
1984-06-25Manufacturing (CMC) · Supplement 19 · standardAP
1983-08-03Labeling · Supplement 18AP
1982-06-16Manufacturing (CMC) · Supplement 17 · standardAP
1979-01-25Manufacturing (CMC) · Supplement 15 · standardAP
1978-10-18Efficacy · Supplement 14AP
1976-05-14Labeling · Supplement 12AP
1976-05-10Manufacturing (CMC) · Supplement 11 · standardAP
1976-01-23Manufacturing (CMC) · Supplement 10 · standardAP
1976-01-23Manufacturing (CMC) · Supplement 9 · standardAP
1975-07-30Manufacturing (CMC) · Supplement 8 · standardAP
1971-01-26Type 4 - New Combination · 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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