← FDA DRUG APPROVALS

FDA ANDA · ANDA204559

POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVORED

Sponsor: STRIDES PHARMA

APPLICATION
ANDA204559
TYPE
ANDA
ORIGINAL APPROVAL
2015-04-13
LATEST ACTION
2024-06-06
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

2024-06-06Labeling · Supplement 19 · standardAP
2024-06-06Labeling · Supplement 16 · standardAP
2015-04-13UNKNOWN · 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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