Treats opioid addiction (heroin or other morphine-like drugs). ANDA 74184, held by Specgx LLC. Methadone Hydrochloride.
As of Nov 15, 2026, ANDA 74184 (Methadose), held by Specgx LLC, was first approved by FDA on Apr 29, 1993, with 8 approved supplements and 0 published complete response letters.
Methadone hydrochloride tablets for oral suspension contain 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 42 CFR 8.12.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 1993 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methadose40MG · tablet, for suspension;oral | Methadone Hydrochloride | Rx |
| Sep 18, 2018 | Supplement 22REMS | Approved | None posted |
| Dec 13, 2014 | Supplement 16Labeling · Standard review | Approved | None posted |
| Nov 9, 2009 | Supplement 12Labeling | Approved | None posted |
| Apr 4, 2007 | Supplement 11Labeling | Approved | None posted |
| Mar 23, 2006 | Supplement 10Labeling | Approved | None posted |
| Nov 28, 2000 | Supplement 4Manufacturing | Approved | None posted |
| Nov 21, 1995 | Supplement 2Manufacturing | Approved | None posted |
| Sep 29, 1994 | Supplement 1Manufacturing | Approved | None posted |
| Apr 29, 1993 | Original application | Approved | None posted |
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
