Actualités réglementaires
18 sept. 2026•1 min de lecture
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.
Actualités réglementaires
12 sept. 2026•1 min de lecture
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.
Actualités réglementaires
9 sept. 2026•1 min de lecture
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.
Actualités réglementaires
9 sept. 2026•1 min de lecture
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.
Actualités réglementaires
24 août 2026•1 min de lecture
FDA Approves Ondansetron Injectable (ANDA077473)
The FDA has approved ANDA077473 for ondansetron injectable, manufactured by Hospira, for intramuscular and intravenous use.