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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216095
Company: LUPIN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE 0.225GM;0.188GM;1.479GM TABLET;ORAL Prescription AB No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/28/2026 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216095Orig1s000TAltr.pdf

SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE

TABLET;ORAL; 0.225GM;0.188GM;1.479GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE 0.225GM;0.188GM;1.479GM TABLET;ORAL Prescription No AB 216095 LUPIN
SUTAB MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE 0.225GM;0.188GM;1.479GM TABLET;ORAL Prescription Yes AB 213135 AZURITY
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