Issued to LUPIN. Application is approved as submitted.
Issued
July 22, 2026Application
ANDA 505j • 216095
Product
SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE
Company
LUPIN
Stage
Final Decision
Assyro regulatory brief
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FDA issued an approval letter for SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE on 2026-07-22. The source metadata identifies ANDA 216095 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
This letter documents an FDA approval action: FDA approved ANDA 216095 for SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE, sponsored by LUPIN, on July 22, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
ANDA 216095 is the application under which FDA issued this approval letter for SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE to LUPIN. The letter is dated July 22, 2026.
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.