ANDA 84050, held by Nexgen Pharma Inc. Isoniazid.
As of Nov 15, 2026, ANDA 84050 (Isoniazid), held by Nexgen Pharma Inc, was first approved by FDA on Oct 22, 1974, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 22, 1974 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Isoniazid100MG 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
