APPLICATION
NDA016983
TYPE
NDA
ORIGINAL APPROVAL
1971-08-06
LATEST ACTION
2017-04-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CONRAY 30 · ReferenceDiscontinued
IOTHALAMATE MEGLUMINE 30% · INJECTABLE · INJECTION
Approval history
2013-12-19Manufacturing (CMC) · Supplement 32 · standardAP
2013-05-10Manufacturing (CMC) · Supplement 30 · standardAP
1999-10-27Manufacturing (CMC) · Supplement 29 · standardAP
1995-01-13Labeling · Supplement 28 · standardAP
1992-12-04Manufacturing (CMC) · Supplement 26 · standardAP
1992-08-28Manufacturing (CMC) · Supplement 27 · standardAP
1990-03-30Manufacturing (CMC) · Supplement 25 · standardAP
1989-12-01Manufacturing (CMC) · Supplement 23 · standardAP
1989-10-10Manufacturing (CMC) · Supplement 22 · standardAP
1989-06-28Manufacturing (CMC) · Supplement 18 · standardAP
1989-06-12Labeling · Supplement 24AP
1985-09-09Efficacy · Supplement 20AP
1985-04-08Manufacturing (CMC) · Supplement 21 · standardAP
1984-12-04Manufacturing (CMC) · Supplement 17 · standardAP
1984-11-07Labeling · Supplement 19AP
1984-06-25Manufacturing (CMC) · Supplement 16 · standardAP
1982-08-16Labeling · Supplement 15AP
1982-08-16Labeling · Supplement 13AP
1981-08-24Manufacturing (CMC) · Supplement 14 · standardAP
1977-06-20Efficacy · Supplement 9AP
1976-09-08Manufacturing (CMC) · Supplement 11 · standardAP
1976-05-05Manufacturing (CMC) · Supplement 8 · standardAP
1976-05-05Labeling · Supplement 10AP
1976-01-23Manufacturing (CMC) · Supplement 7 · standardAP
1976-01-23Manufacturing (CMC) · Supplement 6 · standardAP
1975-07-30Manufacturing (CMC) · Supplement 5 · standardAP
1971-08-06Type 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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