APPLICATION
ANDA040241
TYPE
ANDA
ORIGINAL APPROVAL
1998-05-29
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHADONE HYDROCHLORIDEDiscontinued
METHADONE HYDROCHLORIDE 10MG · TABLET · ORAL
METHADONE HYDROCHLORIDEDiscontinued
METHADONE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 30AP
2025-12-23Labeling · Supplement 29 · standardAP
2025-12-22Labeling · Supplement 27 · standardAP
2024-10-31REMS · Supplement 28AP
2023-12-15Labeling · Supplement 26 · standardAP
2018-09-18REMS · Supplement 19AP
2017-05-26REMS · Supplement 18AP
2016-10-31Manufacturing (CMC) · Supplement 15 · unknownAP
2016-09-30REMS · Supplement 16AP
2016-04-20REMS · Supplement 14AP
2015-06-26REMS · Supplement 12AP
2015-05-29Labeling · Supplement 13 · standardAP
2014-12-19Labeling · Supplement 9 · standardAP
2014-08-19REMS · Supplement 11AP
2013-04-15REMS · Supplement 8AP
2012-07-09Labeling · Supplement 7AP
2012-07-09REMS · Supplement 6AP
2007-02-05Labeling · Supplement 4AP
2000-02-02Manufacturing (CMC) · Supplement 1AP
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.
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