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FDA ANDA · ANDA090019

GAVILYTE-N

polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate

Sponsor: NOVEL LABS INC

APPLICATION
ANDA090019
TYPE
ANDA
ORIGINAL APPROVAL
2009-05-27
LATEST ACTION
2023-06-23
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription

Products

PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDEPrescription
POLYETHYLENE GLYCOL 3350 420GM/BOT, POTASSIUM CHLORIDE 1.48GM/BOT, SODIUM BICARBONATE 5.72GM/BOT, SODIUM CHLORIDE 11.2GM/BOT · FOR SOLUTION · ORAL

Approval history

2023-06-23Labeling · Supplement 15 · standardAP
2020-12-21Labeling · Supplement 8 · standardAP
2009-10-05Labeling · Supplement 1AP
2009-05-27OriginalAP
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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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