APPLICATION
NDA011324
TYPE
NDA
ORIGINAL APPROVAL
1958-08-22
LATEST ACTION
2013-08-29
ROUTE
INTRAUTERINE
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
SINOGRAFIN · ReferenceDiscontinued
DIATRIZOATE MEGLUMINE 52.7%, IODIPAMIDE MEGLUMINE 26.8% · SOLUTION · INTRAUTERINE
Approval history
2013-08-29Manufacturing (CMC) · Supplement 33 · standardAP
2000-03-16Manufacturing (CMC) · Supplement 30 · standardAP
1994-04-29Manufacturing (CMC) · Supplement 29 · standardAP
1985-08-06Manufacturing (CMC) · Supplement 25 · standardAP
1985-01-28Manufacturing (CMC) · Supplement 27 · standardAP
1983-08-03Manufacturing (CMC) · Supplement 23 · standardAP
1983-07-22Labeling · Supplement 22AP
1983-06-03Manufacturing (CMC) · Supplement 24 · standardAP
1979-07-11Manufacturing (CMC) · Supplement 21 · standardAP
1979-06-26Labeling · Supplement 20AP
1979-02-15Manufacturing (CMC) · Supplement 14 · standardAP
1979-02-15Manufacturing (CMC) · Supplement 19 · standardAP
1978-12-28Manufacturing (CMC) · Supplement 18 · standardAP
1978-12-28Manufacturing (CMC) · Supplement 17 · standardAP
1978-09-25Manufacturing (CMC) · Supplement 15 · standardAP
1978-05-31Manufacturing (CMC) · Supplement 16 · standardAP
1978-05-31Labeling · Supplement 10AP
1977-04-04Manufacturing (CMC) · Supplement 13 · standardAP
1977-01-11Manufacturing (CMC) · Supplement 11 · standardAP
1976-05-05Manufacturing (CMC) · Supplement 9 · standardAP
1975-09-25Manufacturing (CMC) · Supplement 8 · standardAP
1975-05-29Manufacturing (CMC) · Supplement 7 · standardAP
1958-08-22Type 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.