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FDA ANDA · ANDA202217

GAVILYTE-H AND BISACODYL

polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride and bisacodyl delayed-release tablet

Sponsor: NOVEL LABS INC

APPLICATION
ANDA202217
TYPE
ANDA
ORIGINAL APPROVAL
2014-08-20
LATEST ACTION
2021-05-14
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION, TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYLDiscontinued
BISACODYL 5MG,N/A, POLYETHYLENE GLYCOL 3350 N/A,210GM, POTASSIUM CHLORIDE N/A,0.74GM, SODIUM BICARBONATE N/A,2.86GM, SODIUM CHLORIDE N/A,5.6GM · FOR SOLUTION, TABLET, DELAYED RELEASE · ORAL

Approval history

2021-05-14Labeling · Supplement 4 · standardAP
2014-08-20Not Applicable · OriginalAP
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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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