Actualités réglementaires30 août 2026•1 min de lecture

FDA Approves ANDA076885 for Rabeprazole Sodium

Par l'équipe PharmaCountry

FDA has approved ANDA076885 for Rabeprazole Sodium oral delayed‑release tablets (20 mg) sponsored by Pharmobedient, with multiple labeling submissions approved between 2013 and 2023.

The FDA's database shows that ANDA076885 pertains to Rabeprazole Sodium, an oral delayed‑release tablet (20 mg) marketed under product number 001. The product is listed as discontinued and is not a reference drug. The application is sponsored by Pharmobedient. The original submission (submission 1) received approval on 8 Nov 2013, with associated label and letters dated 19 Nov 2013, 20 Jan 2006, and 13 Nov 2013. Subsequent supplemental labeling submissions (numbers 2‑11) have also been approved between 2015 and 2023. All submissions are classified under standard review priority and pertain to labeling updates. The latest labeling supplement (submission 11) was approved on 31 Oct 2023.

Compilé par l'équipe PharmaCountry · Source : FDA.gov

Sujets :#Rabeprazole #ANDA #FDA #Oral Tablet #labeling #pharmaceutical regulation