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FDA NDA · NDA011245

GASTROGRAFIN

diatrizoate meglumine and diatrizoate sodium

Sponsor: BRACCO

APPLICATION
NDA011245
TYPE
NDA
ORIGINAL APPROVAL
1958-01-17
LATEST ACTION
2005-08-29
ROUTE
ORAL, RECTAL, ORAL, RECTAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

GASTROGRAFIN · ReferencePrescription
DIATRIZOATE MEGLUMINE 66%, DIATRIZOATE SODIUM 10% · SOLUTION · ORAL, RECTAL

Approval history

2005-08-29Manufacturing (CMC) · Supplement 32 · standard — Letter ↗AP
2000-12-15Manufacturing (CMC) · Supplement 30 · standardAP
1994-08-05Labeling · Supplement 29 · standardAP
1994-05-19Manufacturing (CMC) · Supplement 28 · standardAP
1991-03-05Manufacturing (CMC) · Supplement 27 · standardAP
1985-01-28Manufacturing (CMC) · Supplement 26 · standardAP
1983-09-14Efficacy · Supplement 20AP
1983-09-14Labeling · Supplement 23AP
1983-08-03Manufacturing (CMC) · Supplement 22 · standardAP
1983-02-02Labeling · Supplement 21AP
1979-09-13Labeling · Supplement 19AP
1978-12-28Manufacturing (CMC) · Supplement 18 · standardAP
1978-09-16Manufacturing (CMC) · Supplement 16 · standardAP
1978-02-27Manufacturing (CMC) · Supplement 17 · standardAP
1976-09-08Labeling · Supplement 12AP
1975-09-25Manufacturing (CMC) · Supplement 13 · standardAP
1958-01-17Type 3 - New Dosage Form · Original · standardAP
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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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