APPLICATION
ANDA208305
TYPE
ANDA
ORIGINAL APPROVAL
2018-03-30
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHADONE HYDROCHLORIDEDiscontinued
METHADONE HYDROCHLORIDE 5MG · TABLET · ORAL
METHADONE HYDROCHLORIDEDiscontinued
METHADONE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 10AP
2025-12-22Labeling · Supplement 9 · standardAP
2025-12-22Labeling · Supplement 7 · standardAP
2024-10-31REMS · Supplement 8AP
2023-12-15Labeling · Supplement 6 · standardAP
2021-06-02Labeling · Supplement 5 · standardAP
2021-02-18Labeling · Supplement 4 · standardAP
2018-09-18REMS · Supplement 2AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.