Treats opioid addiction (heroin or other morphine-like drugs). ANDA 212093, held by Lannett Co Inc. Methadone Hydrochloride.
As of Nov 15, 2026, ANDA 212093 (Methadone Hydrochloride), held by Lannett Co Inc, was first approved by FDA on Nov 2, 2020, with 4 approved supplements and 0 published complete response letters.
Methadone Hydrochloride contains methadone, an opioid agonist indicated for the: detoxification treatment of opioid addiction (heroin or other morphine-like drugs). maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. Limitations of Use Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 21 CFR, Title 42, Sec 8. Methadone Hydrochloride is an opioid agonist indicated for the: Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 2, 2020 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methadone Hydrochloride10MG/ML · concentrate;oral | Methadone Hydrochloride | Rx |
| Jul 17, 2026 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 17, 2026 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jul 17, 2026 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jul 17, 2026 | Supplement 7Labeling · Standard review | Approved | None posted |
| Nov 2, 2020 | Original application | Approved |
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
