APPLICATION
NDA016847
TYPE
NDA
ORIGINAL APPROVAL
1973-11-17
LATEST ACTION
1979-02-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ISOPAQUE 440Discontinued
CALCIUM METRIZOATE 0.78MG/ML, MEGLUMINE METRIZOATE 75.9MG/ML, METRIZOATE MAGNESIUM 0.15MG/ML, METRIZOATE SODIUM 16.6MG/ML · INJECTABLE · INJECTION
Approval history
1979-02-15Manufacturing (CMC) · Supplement 8 · standardAP
1978-02-01Manufacturing (CMC) · Supplement 7 · standardAP
1977-09-14Manufacturing (CMC) · Supplement 6 · standardAP
1977-09-14Labeling · Supplement 4AP
1977-08-10Manufacturing (CMC) · Supplement 5 · standardAP
1976-03-26Manufacturing (CMC) · Supplement 2 · standardAP
1975-11-21Labeling · Supplement 3AP
1973-11-17Type 2 New Active Ingredient and Type 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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