← FDA DRUG APPROVALS

FDA NDA · NDA215344

SUFLAVE

polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution

Sponsor: AZURITY

APPLICATION
NDA215344
TYPE
NDA
ORIGINAL APPROVAL
2023-06-15
LATEST ACTION
2023-06-15
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription

Products

SUFLAVE · ReferencePrescription
MAGNESIUM SULFATE 0.9GM/BOT, POLYETHYLENE GLYCOL 3350 178.7GM/BOT, POTASSIUM CHLORIDE 1.12GM/BOT, SODIUM CHLORIDE 0.5GM/BOT, SODIUM SULFATE 7.3GM/BOT · FOR SOLUTION · ORAL

Approval history

2023-06-15Type 4 - New Combination · Original · standard — Label ↗AP
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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