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FDA ANDA · ANDA216095

SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE

Sponsor: LUPIN

APPLICATION
ANDA216095
TYPE
ANDA
ORIGINAL APPROVAL
2026-05-28
LATEST ACTION
2026-05-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDEPrescription
MAGNESIUM SULFATE 0.225GM, POTASSIUM CHLORIDE 0.188GM, SODIUM SULFATE 1.479GM · TABLET · ORAL

Approval history

2026-05-28UNKNOWN · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

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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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