FDAsafety guidance65% confidence
FDA AP — DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Aurobindo Pharma.
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
- Diabetes · SGLT2 Inhibitor and Biguanide
- Sub-indication
- General
Related signal: Aurobindo Pharma submits ANDA for Empagliflozin and Metformin Hydrochloride