Baxter Healthcare Corporation et al.; Withdrawal of Approval of One New Drug Application and Four Abbreviated New Drug Applications

摘要

The Food and Drug Administration (FDA) is withdrawing approval of one new drug application (NDA) for Ondansetron (ondansetron hydrochloride (HCl)) Injection, USP in PL 2408 Plastic Container, 32 milligrams (mg) in 50 milliliters (mL), single intravenous (IV) dose, and four abbreviated new drug applications (ANDAs) for ondansetron HCl and Dextrose in 32 mg single IV doses. The holders of these applications have voluntarily requested that FDA withdraw approval of their applications and have waived their opportunity for a hearing.