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FDA ANDA · ANDA204558

POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVORED

Sponsor: STRIDES PHARMA

APPLICATION
ANDA204558
TYPE
ANDA
ORIGINAL APPROVAL
2018-12-21
LATEST ACTION
2024-06-12
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription

Products

POLYETHYLENE GLYCOL 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

2024-06-12Labeling · Supplement 7 · standardAP
2024-06-12Labeling · Supplement 5 · standardAP
2024-06-12Labeling · Supplement 10 · standardAP
2018-12-21UNKNOWN · 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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