APPLICATION
NDA010040
TYPE
NDA
ORIGINAL APPROVAL
1955-08-02
LATEST ACTION
2015-07-06
ROUTE
INTRAVESICAL, INTRAVENOUS, INJECTION, URETHRAL, URETERAL
DOSAGE FORM
INJECTABLE, SOLUTION
MARKETING STATUS
Discontinued, Prescription
Products
RENOGRAFIN-76 · ReferenceDiscontinued
DIATRIZOATE MEGLUMINE 66%, DIATRIZOATE SODIUM 10% · INJECTABLE · INJECTION
CYSTOGRAFIN · ReferencePrescription
DIATRIZOATE MEGLUMINE 30% · SOLUTION · URETHRAL
RENO-60Discontinued
DIATRIZOATE MEGLUMINE 60% · INJECTABLE · INJECTION
CYSTOGRAFIN DILUTE · ReferencePrescription
DIATRIZOATE MEGLUMINE 18% · SOLUTION · URETHRAL
RENOGRAFIN-60Discontinued
DIATRIZOATE MEGLUMINE 52%, DIATRIZOATE SODIUM 8% · INJECTABLE · INJECTION
RENOVISTDiscontinued
DIATRIZOATE MEGLUMINE 34.3%, DIATRIZOATE SODIUM 35% · INJECTABLE · INJECTION
RENO-DIPDiscontinued
DIATRIZOATE MEGLUMINE 30% · INJECTABLE · INJECTION
RENOVIST IIDiscontinued
DIATRIZOATE MEGLUMINE 28.5%, DIATRIZOATE SODIUM 29.1% · INJECTABLE · INJECTION
DIATRIZOATE MEGLUMINEDiscontinued
DIATRIZOATE MEGLUMINE 76% · INJECTABLE · INJECTION
RENO-30Discontinued
DIATRIZOATE MEGLUMINE 30% · SOLUTION · URETERAL
Approval history
2000-06-29Manufacturing (CMC) · Supplement 167 · standardAP
1994-09-09Labeling · Supplement 166 · standardAP
1991-03-05Manufacturing (CMC) · Supplement 134 · standardAP
1989-07-07Labeling · Supplement 162AP
1987-06-08Manufacturing (CMC) · Supplement 160 · standardAP
1985-11-25Labeling · Supplement 159AP
1985-07-23Labeling · Supplement 158AP
1985-07-23Labeling · Supplement 152AP
1985-07-23Labeling · Supplement 150AP
1985-07-23Labeling · Supplement 157AP
1985-07-23Labeling · Supplement 153AP
1985-06-12Labeling · Supplement 148AP
1985-06-12Labeling · Supplement 146AP
1985-06-12Labeling · Supplement 149AP
1985-06-06Labeling · Supplement 156AP
1985-06-06Labeling · Supplement 154AP
1985-06-06Labeling · Supplement 147AP
1985-06-06Labeling · Supplement 151AP
1985-06-05Labeling · Supplement 155AP
1985-05-23Manufacturing (CMC) · Supplement 144 · standardAP
1985-05-23Manufacturing (CMC) · Supplement 142 · standardAP
1985-01-28Manufacturing (CMC) · Supplement 145 · standardAP
1985-01-14Manufacturing (CMC) · Supplement 138 · standardAP
1984-04-03Efficacy · Supplement 143AP
1984-01-06Manufacturing (CMC) · Supplement 139 · standardAP
1983-07-10Efficacy · Supplement 107AP
1983-02-02Labeling · Supplement 140AP
1983-01-26Labeling · Supplement 109AP
1982-11-09Manufacturing (CMC) · Supplement 137 · standardAP
1982-09-27Efficacy · Supplement 121AP
1982-06-30Labeling · Supplement 105AP
1982-06-30Labeling · Supplement 111AP
1982-03-31Labeling · Supplement 122AP
1982-02-24Manufacturing (CMC) · Supplement 135 · standardAP
1981-07-01Manufacturing (CMC) · Supplement 120 · standardAP
1980-08-01Labeling · Supplement 118AP
1980-07-01Labeling · Supplement 116AP
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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