ANDA 80134, held by Medpointe Pharm Hlc. Isoniazid.
As of Nov 15, 2026, ANDA 80134 (Hyzyd), held by Medpointe Pharm Hlc, was not approved, with 0 approved supplements and 0 published complete response letters.
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
