APPLICATION
NDA009561
TYPE
NDA
ORIGINAL APPROVAL
1954-11-26
LATEST ACTION
2001-08-13
ROUTE
URETERAL, INJECTION
DOSAGE FORM
SOLUTION, INJECTABLE
MARKETING STATUS
Discontinued
Products
HYPAQUE SODIUM 20%Discontinued
DIATRIZOATE SODIUM 20% · SOLUTION · URETERAL
HYPAQUEDiscontinued
DIATRIZOATE SODIUM 25% · INJECTABLE · INJECTION
HYPAQUEDiscontinued
DIATRIZOATE SODIUM 50% · INJECTABLE · INJECTION
Approval history
2001-08-13Manufacturing (CMC) · Supplement 79 · priorityAP
1998-08-20Manufacturing (CMC) · Supplement 78 · priorityAP
1996-08-23Manufacturing (CMC) · Supplement 76 · priorityAP
1995-06-15Labeling · Supplement 77 · priorityAP
1993-10-05Manufacturing (CMC) · Supplement 75 · priorityAP
1991-10-03Labeling · Supplement 72 · priorityAP
1991-10-03Labeling · Supplement 73 · priorityAP
1991-10-03Labeling · Supplement 71 · priorityAP
1990-02-26Manufacturing (CMC) · Supplement 62 · priorityAP
1989-06-29Labeling · Supplement 70 · priorityAP
1989-05-26Labeling · Supplement 69 · priorityAP
1989-05-02Labeling · Supplement 68 · priorityAP
1989-04-11Manufacturing (CMC) · Supplement 67 · priorityAP
1988-05-23Manufacturing (CMC) · Supplement 56 · priorityAP
1988-02-22Labeling · Supplement 66 · priorityAP
1987-08-24Labeling · Supplement 64 · priorityAP
1987-03-23Manufacturing (CMC) · Supplement 55 · priorityAP
1987-02-01Labeling · Supplement 48 · priorityAP
1986-11-07Labeling · Supplement 63 · priorityAP
1986-08-14Manufacturing (CMC) · Supplement 59 · priorityAP
1986-08-06Manufacturing (CMC) · Supplement 42 · priorityAP
1986-06-25Labeling · Supplement 61 · priorityAP
1986-03-17Labeling · Supplement 60 · priorityAP
1985-06-26Labeling · Supplement 58 · priorityAP
1985-04-19Labeling · Supplement 57 · priorityAP
1985-01-14Manufacturing (CMC) · Supplement 53 · priorityAP
1984-04-05Labeling · Supplement 46 · priorityAP
1984-02-29Labeling · Supplement 45 · priorityAP
1983-08-03Manufacturing (CMC) · Supplement 50 · priorityAP
1982-10-18Manufacturing (CMC) · Supplement 52 · priorityAP
1982-06-30Labeling · Supplement 40 · priorityAP
1982-03-18Manufacturing (CMC) · Supplement 49 · priorityAP
1982-02-24Labeling · Supplement 47 · priorityAP
1982-01-18Manufacturing (CMC) · Supplement 43 · priorityAP
1981-04-11Manufacturing (CMC) · Supplement 41 · priorityAP
1979-10-11Manufacturing (CMC) · Supplement 39 · priorityAP
1979-02-15Manufacturing (CMC) · Supplement 37 · priorityAP
1979-01-22Manufacturing (CMC) · Supplement 38 · priorityAP
1978-10-06Labeling · Supplement 33 · priorityAP
1978-02-01Manufacturing (CMC) · Supplement 36 · priorityAP
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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