APPLICATION
NDA013295
TYPE
NDA
ORIGINAL APPROVAL
1962-08-16
LATEST ACTION
2023-04-26
ROUTE
INTRAVASCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
CONRAY 43 · ReferenceDiscontinued
IOTHALAMATE MEGLUMINE 43% · INJECTABLE · INJECTION
CONRAY · ReferencePrescription
IOTHALAMATE MEGLUMINE 60% · INJECTABLE · INJECTION
Approval history
2016-06-22Manufacturing (CMC) · Supplement 69 · priorityAP
2015-02-03Manufacturing (CMC) · Supplement 67 · priorityAP
2014-02-25Manufacturing (CMC) · Supplement 65 · priorityAP
2013-12-19Manufacturing (CMC) · Supplement 64 · priorityAP
2013-07-23Manufacturing (CMC) · Supplement 63 · priorityAP
2013-05-30Manufacturing (CMC) · Supplement 62 · priorityAP
2013-05-10Manufacturing (CMC) · Supplement 61 · priorityAP
2001-02-26Manufacturing (CMC) · Supplement 59 · priorityAP
1999-10-27Manufacturing (CMC) · Supplement 58 · priorityAP
1995-01-13Labeling · Supplement 57 · standardAP
1992-12-04Manufacturing (CMC) · Supplement 55 · priorityAP
1992-08-28Manufacturing (CMC) · Supplement 56 · priorityAP
1990-03-30Manufacturing (CMC) · Supplement 54 · priorityAP
1989-12-01Manufacturing (CMC) · Supplement 52 · priorityAP
1989-10-10Manufacturing (CMC) · Supplement 50 · priorityAP
1989-10-10Manufacturing (CMC) · Supplement 43 · priorityAP
1989-06-28Manufacturing (CMC) · Supplement 44 · priorityAP
1989-06-28Labeling · Supplement 53AP
1988-08-19Manufacturing (CMC) · Supplement 51 · priorityAP
1986-12-18Labeling · Supplement 49AP
1985-09-09Efficacy · Supplement 47AP
1985-04-08Manufacturing (CMC) · Supplement 48 · priorityAP
1984-12-04Manufacturing (CMC) · Supplement 42 · priorityAP
1984-10-25Labeling · Supplement 46AP
1984-09-12Labeling · Supplement 45AP
1984-06-25Manufacturing (CMC) · Supplement 41 · priorityAP
1984-06-19Labeling · Supplement 40AP
1983-02-25Labeling · Supplement 34AP
1983-01-26Efficacy · Supplement 33AP
1983-01-26Labeling · Supplement 36AP
1982-10-22Labeling · Supplement 38AP
1982-10-20Efficacy · Supplement 31AP
1982-10-20Manufacturing (CMC) · Supplement 39 · priorityAP
1979-12-07Labeling · Supplement 32AP
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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