Sulfamethazine: FDA Statement

This original ANADA submitted under section 512(b) of the Federal Food, Drug, and  Cosmetic Act satisfies the requirements of section 512(n) of the act and demonstrates that  SMZ-MED 454 Soluble Powder, when used under its proposed conditions of use, is safe and  effective for its labeled  indications.

Read the full FDA statement and also the information about sulfamethazine possible side effects.