規制動向
2026年9月18日•1分で読めます
FDA Approves ANDA078127 for Ondansetron Oral Solution
The FDA has approved application ANDA078127 for an oral ondansetron solution (4 mg/5 mL) marketed by PAI Holdings, LLC dba PAI Pharma.
規制動向
2026年9月12日•1分で読めます
FDA Approves ANDA077545 for Ondansetron Hydrochloride Tablets
FDA approved application ANDA077545 from Hikma International Pharmaceuticals for discontinued oral ondansetron tablets (4 mg, 8 mg, 24 mg) with multiple labeling supplements approved.
規制動向
2026年9月9日•1分で読めます
FDA Approves ANDA078152 for Oral Ondansetron Tablets (4 mg & 8 mg)
The FDA has approved ANDA078152 for prescription oral ondansetron tablets in 4 mg and 8 mg strengths, submitted by AvKARE, Glenmark and BluePoint.
規制動向
2026年9月9日•1分で読めます
FDA Approves Sandoz Ondansetron Hydrochloride Preservative‑Free Injection (ANDA 077551)
Sandoz received FDA approval for a generic ondansetron hydrochloride injection (preservative‑free) under ANDA 077551, with original and supplemental labeling approvals dating from 2007 to 2015.
規制動向
2026年8月24日•1分で読めます
FDA Approves Ondansetron Injectable (ANDA077473)
The FDA has approved ANDA077473 for ondansetron injectable, manufactured by Hospira, for intramuscular and intravenous use.