APPLICATION
NDA017506
TYPE
NDA
ORIGINAL APPROVAL
1974-04-30
LATEST ACTION
2007-12-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ISOPAQUE 280Discontinued
CALCIUM 0.35MG/ML, MEGLUMINE 140.1MG/ML, METRIZOIC ACID 461.8MG/ML · INJECTABLE · INJECTION
Approval history
2007-12-07Labeling · Supplement 3AP
1978-02-01Manufacturing (CMC) · Supplement 4 · standardAP
1976-06-04Labeling · Supplement 2AP
1974-06-10Manufacturing (CMC) · Supplement 1 · standardAP
1974-04-30Type 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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