FDAsafety guidance66% confidence
FDA AP — SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE (ORIG)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Lupin Ltd.; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA216095. Sponsor: LUPIN. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: MAGNESIUM SULFATE, POTASSIUM CHLORIDE, SODIUM SULFATE.
Supporting Context
- Therapeutic area
- Cardiovascular · Antihypertensive
- Sub-indication
- General
Related signal: Lupin's ANDA078232 for Losartan Potassium Receives AP Status from FDA