FDAsafety guidance77% confidence
FDA AP — LITHIUM CARBONATE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Dr. Reddy's; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA076832. Sponsor: HIKMA. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LITHIUM CARBONATE.
Supporting Context
- Therapeutic area
- Hematology · Vitamin K
- Sub-indication
- General
Related signal: FDA Grants AP Status for Dr. Reddy's PHYTONADIONE ANDA215820