Treats opioid addiction (heroin or other morphine-like drugs). ANDA 40180, held by Hikma. Methadone Hydrochloride.
As of Nov 15, 2026, ANDA 40180 (Methadone Hydrochloride), held by Hikma, was first approved by FDA on Apr 30, 1998, with 5 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For 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 (see DOSAGE AND ADMINISTRATION ).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 30, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methadone Hydrochloride10MG/ML · concentrate;oral | Methadone Hydrochloride | Rx |
| May 31, 2024 | Supplement 12Labeling · Standard review | Approved | None posted |
| May 31, 2024 | Supplement 13Labeling · Standard review | Approved | None posted |
| Apr 25, 2007 | Supplement 3Labeling | Approved | None posted |
| Oct 28, 1999 | Supplement 1Manufacturing | Approved | None posted |
| Oct 28, 1999 | Supplement 2Manufacturing | Approved | None posted |
| Apr 30, 1998 | 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
