Neoral

NDA 50737, held by Novartis. Cyclosporine.

As of Nov 13, 2026, NDA 50737 (Neoral), held by Novartis, was first approved by FDA on Jun 19, 1997, with 1 approved supplement and 0 published complete response letters.

• First approved: Jun 19, 1997
• Review: Standard
• Supplements approved: 1
• Complete response letters: 0

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters