Diutensen-R

NDA 12708, held by Medpointe Pharm Hlc. Methyclothiazide; Reserpine.

As of Nov 14, 2026, NDA 12708 (Diutensen-R), held by Medpointe Pharm Hlc, was not approved, with 1 approved supplement and 0 published complete response letters.

• First approved: Not approved
• 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