Manages severe and persistent pain. ANDA 218252, held by Breckenridge. Methadone Hydrochloride.
As of Nov 15, 2026, ANDA 218252 (Methadone Hydrochloride), held by Breckenridge, was first approved by FDA on Dec 16, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Methadone Hydrochloride Injection is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration (see WARNINGS ), and persist over the course of therapy, reserve opioid analgesics, including Methadone Hydrochloride Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 16, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methadone Hydrochloride10MG/ML · injectable;injection | Methadone Hydrochloride | Rx |
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
