ANDA 74081, held by Roxane. Methadone Hydrochloride.
As of Nov 15, 2026, ANDA 74081 (Methadone Hydrochloride), held by Roxane, was first approved by FDA on Apr 28, 1995, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 28, 1995 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methadone Hydrochloride40MG ยท tablet;oral | Methadone Hydrochloride | 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
