APPLICATION
NDA016403
TYPE
NDA
ORIGINAL APPROVAL
1969-08-21
LATEST ACTION
2002-09-30
ROUTE
INJECTION, URETHRAL
DOSAGE FORM
INJECTABLE, SOLUTION
MARKETING STATUS
Discontinued
Products
HYPAQUEDiscontinued
DIATRIZOATE MEGLUMINE 60% · INJECTABLE · INJECTION
HYPAQUEDiscontinued
DIATRIZOATE MEGLUMINE 30% · INJECTABLE · INJECTION
HYPAQUE-CYSTODiscontinued
DIATRIZOATE MEGLUMINE 30% · SOLUTION · URETHRAL
Approval history
2001-08-13Manufacturing (CMC) · Supplement 70 · priorityAP
1998-08-20Manufacturing (CMC) · Supplement 69 · priorityAP
1995-06-15Labeling · Supplement 68 · priorityAP
1994-03-25Manufacturing (CMC) · Supplement 67 · priorityAP
1991-10-03Labeling · Supplement 66 · priorityAP
1991-10-03Labeling · Supplement 64 · priorityAP
1991-10-03Labeling · Supplement 65 · priorityAP
1991-04-24Manufacturing (CMC) · Supplement 63 · priorityAP
1990-02-26Manufacturing (CMC) · Supplement 53 · priorityAP
1989-10-26Manufacturing (CMC) · Supplement 62 · priorityAP
1989-06-28Labeling · Supplement 61 · priorityAP
1989-06-22Manufacturing (CMC) · Supplement 56 · priorityAP
1989-06-22Manufacturing (CMC) · Supplement 57 · priorityAP
1989-05-26Labeling · Supplement 60 · priorityAP
1989-05-19Labeling · Supplement 59 · priorityAP
1989-04-18Manufacturing (CMC) · Supplement 58 · priorityAP
1989-04-11Manufacturing (CMC) · Supplement 55 · priorityAP
1988-05-23Manufacturing (CMC) · Supplement 46 · priorityAP
1988-02-22Labeling · Supplement 54 · priorityAP
1986-02-10Labeling · Supplement 52 · priorityAP
1985-11-22Labeling · Supplement 51 · priorityAP
1985-09-11Manufacturing (CMC) · Supplement 41 · priorityAP
1985-04-23Labeling · Supplement 49 · priorityAP
1985-04-19Labeling · Supplement 48 · priorityAP
1985-04-16Labeling · Supplement 50 · priorityAP
1985-01-14Manufacturing (CMC) · Supplement 44 · priorityAP
1984-11-26Labeling · Supplement 47 · priorityAP
1984-03-12Labeling · Supplement 38 · priorityAP
1984-03-12Labeling · Supplement 42 · priorityAP
1984-01-24Efficacy · Supplement 37 · priorityAP
1984-01-16Labeling · Supplement 35 · priorityAP
1983-10-04Manufacturing (CMC) · Supplement 33 · priorityAP
1983-02-28Manufacturing (CMC) · Supplement 40 · priorityAP
1983-01-25Manufacturing (CMC) · Supplement 45 · priorityAP
1982-10-18Manufacturing (CMC) · Supplement 43 · priorityAP
1982-03-18Manufacturing (CMC) · Supplement 39 · priorityAP
1982-02-24Manufacturing (CMC) · Supplement 36 · priorityAP
1982-01-18Manufacturing (CMC) · Supplement 34 · priorityAP
1981-04-27Manufacturing (CMC) · Supplement 31 · 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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