ANDA 212094, held by Lannett Co Inc. Methadone Hydrochloride.
As of Nov 15, 2026, ANDA 212094 (Methadone Hydrochloride), held by Lannett Co Inc, was first approved by FDA on Mar 3, 2021, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 3, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methadone Hydrochloride10MG/ML ยท concentrate;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
