ANDA 83610, held by Ivax Sub Teva Pharms. Isoniazid.
As of Nov 15, 2026, ANDA 83610 (Isoniazid), held by Ivax Sub Teva Pharms, was first approved by FDA on Jan 15, 1974, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 15, 1974 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Isoniazid300MG ยท tablet;oral | Isoniazid | Discontinued |
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
