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FDA ANDA · ANDA087388

MD GASTROVIEW

diatrizoate meglumine and diatrizoate sodium

Sponsor: LIEBEL-FLARSHEIM

APPLICATION
ANDA087388
TYPE
ANDA
ORIGINAL APPROVAL
1981-09-02
LATEST ACTION
2009-09-28
ROUTE
ORAL, RECTAL, ORAL, RECTAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

MD-GASTROVIEWPrescription
DIATRIZOATE MEGLUMINE 66%, DIATRIZOATE SODIUM 10% · SOLUTION · ORAL, RECTAL

Approval history

2009-09-28Labeling · Supplement 18AP
2009-09-28Labeling · Supplement 17AP
2009-06-30Labeling · Supplement 16AP
2007-04-26Labeling · Supplement 14AP
2004-07-13Labeling · Supplement 11AP
2004-07-13Labeling · Supplement 12AP
1987-02-27Manufacturing (CMC) · Supplement 8AP
1986-03-21Manufacturing (CMC) · Supplement 4AP
1986-03-21Manufacturing (CMC) · Supplement 5AP
1981-09-02OriginalAP
VIEW ON DRUGS@FDA ↗

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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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