Valium

NDA 16087, held by Roche. Diazepam.

As of Nov 14, 2026, NDA 16087 (Valium), held by Roche, was first approved by FDA on Aug 24, 1966, with 54 approved supplements and 0 published complete response letters.

• First approved: Aug 24, 1966
• Review: Standard
• Supplements approved: 54
• 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