APPLICATION
NDA014295
TYPE
NDA
ORIGINAL APPROVAL
1963-09-30
LATEST ACTION
1995-01-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CONRAY 400Discontinued
IOTHALAMATE SODIUM 66.8% · INJECTABLE · INJECTION
Approval history
1995-01-13Labeling · Supplement 42 · standardAP
1992-12-04Manufacturing (CMC) · Supplement 40 · standardAP
1992-08-28Manufacturing (CMC) · Supplement 37 · standardAP
1992-08-28Manufacturing (CMC) · Supplement 41 · standardAP
1990-03-30Manufacturing (CMC) · Supplement 39 · standardAP
1989-12-01Manufacturing (CMC) · Supplement 36 · standardAP
1989-10-10Manufacturing (CMC) · Supplement 34 · standardAP
1989-07-03Labeling · Supplement 38AP
1988-08-19Manufacturing (CMC) · Supplement 35 · standardAP
1984-12-04Manufacturing (CMC) · Supplement 31 · standardAP
1984-09-12Labeling · Supplement 33AP
1984-06-25Manufacturing (CMC) · Supplement 30 · standardAP
1984-06-19Labeling · Supplement 32AP
1983-04-08Labeling · Supplement 29AP
1982-05-10Labeling · Supplement 28AP
1981-08-27Manufacturing (CMC) · Supplement 27 · standardAP
1978-12-14Efficacy · Supplement 23AP
1978-08-29Manufacturing (CMC) · Supplement 24 · standardAP
1978-05-30Labeling · Supplement 22AP
1976-05-05Manufacturing (CMC) · Supplement 20 · standardAP
1976-05-05Labeling · Supplement 21AP
1976-01-23Manufacturing (CMC) · Supplement 18 · standardAP
1976-01-23Manufacturing (CMC) · Supplement 19 · standardAP
1975-07-30Manufacturing (CMC) · Supplement 17 · standardAP
1963-09-30Type 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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