Kloxxado

NDA 212045, held by Hikma. Naloxone Hydrochloride.

As of Nov 13, 2026, NDA 212045 (Kloxxado), held by Hikma, was first approved by FDA on Apr 29, 2021, with 1 approved supplement and 1 published complete response letter.

• First approved: Apr 29, 2021
• Review: Standard
• Supplements approved: 1
• Complete response letters: 1

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