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FDA ANDA · ANDA090231

GAVILYTE G TM

polyethylene glycol-3350 and electrolytes

Sponsor: NOVEL LABS INC

APPLICATION
ANDA090231
TYPE
ANDA
ORIGINAL APPROVAL
2009-06-01
LATEST ACTION
2009-06-01
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription

Products

PEG 3350 AND ELECTROLYTESPrescription
POLYETHYLENE GLYCOL 3350 236GM/BOT, POTASSIUM CHLORIDE 2.97GM/BOT, SODIUM BICARBONATE 6.74GM/BOT, SODIUM CHLORIDE 5.86GM/BOT, SODIUM SULFATE ANHYDROUS 22.74GM/BOT · FOR SOLUTION · ORAL

Approval history

2009-06-01OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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