APPLICATION
NDA010220
TYPE
NDA
ORIGINAL APPROVAL
1955-11-09
LATEST ACTION
1994-03-25
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HYPAQUE-M,90%Discontinued
DIATRIZOATE MEGLUMINE 60%, DIATRIZOATE SODIUM 30% · INJECTABLE · INJECTION
HYPAQUE-M,75%Discontinued
DIATRIZOATE MEGLUMINE 50%, DIATRIZOATE SODIUM 25% · INJECTABLE · INJECTION
Approval history
1994-03-25Manufacturing (CMC) · Supplement 46 · standardAP
1991-10-03Labeling · Supplement 44 · standardAP
1991-04-24Manufacturing (CMC) · Supplement 43 · standardAP
1990-09-04Labeling · Supplement 45 · standardAP
1990-02-26Manufacturing (CMC) · Supplement 39 · standardAP
1989-06-28Labeling · Supplement 42 · standardAP
1989-05-19Labeling · Supplement 41 · standardAP
1989-04-11Manufacturing (CMC) · Supplement 40 · standardAP
1988-05-23Manufacturing (CMC) · Supplement 33 · standardAP
1986-06-25Labeling · Supplement 38 · standardAP
1986-06-25Labeling · Supplement 37 · standardAP
1985-07-24Labeling · Supplement 36 · standardAP
1985-06-26Labeling · Supplement 35 · standardAP
1984-09-13Labeling · Supplement 34 · standardAP
1984-08-07Labeling · Supplement 30 · standardAP
1983-11-30Manufacturing (CMC) · Supplement 32 · standardAP
1983-02-28Manufacturing (CMC) · Supplement 31 · standardAP
1979-02-17Manufacturing (CMC) · Supplement 29 · standardAP
1978-03-31Labeling · Supplement 28 · standardAP
1978-03-31Labeling · Supplement 25 · standardAP
1978-02-01Manufacturing (CMC) · Supplement 26 · standardAP
1978-02-01Manufacturing (CMC) · Supplement 27 · standardAP
1976-04-08Labeling · Supplement 24 · standardAP
1976-01-26Labeling · Supplement 23 · standardAP
1976-01-21Labeling · Supplement 22 · standardAP
1976-01-21Supplement · Supplement 21 · standardAP
1974-01-29Labeling · Supplement 17 · standardAP
1955-11-09Type 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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