Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
#Ondansetron ×
Actualizaciones regulatorias
18 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
12 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
9 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
9 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
24 ago 2026•1 min de lectura
FDA Approves Ondansetron Injectable (ANDA077473)
The FDA has approved ANDA077473 for ondansetron injectable, manufactured by Hospira, for intramuscular and intravenous use.