ANDA 80368, held by Phoenix Labs Ny. Isoniazid.
As of Nov 15, 2026, ANDA 80368 (Isoniazid), held by Phoenix Labs Ny, was first approved by FDA on Dec 18, 1975, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 18, 1975 | Original application | Approved | None posted |
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
