FDAsafety guidance54% confidence
FDA AP — SITAGLIPTIN AND METFORMIN HYDROCHLORIDE (ORIG)
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 ANDA202426. Sponsor: APOTEX. Submission status: AP. Submission type: ORIG. Active ingredients: METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE.
Supporting Context
- Therapeutic area
- Diabetes · SGLT2 Inhibitor and Biguanide
- Sub-indication
- General
Related signal: Aurobindo Pharma submits ANDA for Empagliflozin and Metformin Hydrochloride