FDA-2026-P-8251

Requests that the FDA to declare that the proposed drug product Bupivacaine Hydrochloride and Epinephrine Bitartrate Injection, 0.25%/ 0.0091 mg/mL in 5 mL prefilled syringes and 0.5%/0.0091 mg/mL in 3 mL and 5 mL prefilled syringes are suitable for consideration in an Abbreviated New Drug Application.