FDAsafety guidance83% confidence
FDA AP — DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Metformin.
Regulatory Analysis
Application ANDA211491. Sponsor: SUN PHARM. Submission status: AP. Submission type: SUPPL. Review priority: UNKNOWN. Active ingredients: DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Aging · Metformin
- Sub-indication
- General
Related signal: Metformin Aging Study to Assess Insulin Sensitivity and Mitochondrial Function