Vituz

NDA 204307, held by Persion. Chlorpheniramine Maleate; Hydrocodone Bitartrate.

As of Nov 13, 2026, NDA 204307 (Vituz), held by Persion, was first approved by FDA on Feb 20, 2013, with 2 approved supplements and 0 published complete response letters.

• First approved: Feb 20, 2013
• Review: Standard
• Supplements approved: 2
• 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