APPLICATION
ANDA040050
TYPE
ANDA
ORIGINAL APPROVAL
1993-04-15
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHADOSEDiscontinued
METHADONE HYDROCHLORIDE 10MG · TABLET · ORAL
METHADOSEDiscontinued
METHADONE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 35AP
2025-12-23Labeling · Supplement 34 · standardAP
2025-06-24Labeling · Supplement 32 · standardAP
2024-10-31REMS · Supplement 33AP
2023-12-15Labeling · Supplement 30 · standardAP
2023-12-15Labeling · Supplement 31 · standardAP
2022-11-23Labeling · Supplement 28 · standardAP
2022-11-23Labeling · Supplement 26 · standardAP
2022-11-23Labeling · Supplement 29 · standardAP
2022-11-23Labeling · Supplement 25 · standardAP
2018-09-18REMS · Supplement 27AP
2017-05-26REMS · Supplement 24AP
2016-09-30REMS · Supplement 22AP
2016-04-20REMS · Supplement 21AP
2015-06-26REMS · Supplement 19AP
2015-06-01Labeling · Supplement 20 · standardAP
2014-08-19REMS · Supplement 18AP
2014-07-23Labeling · Supplement 16 · standardAP
2013-04-15REMS · Supplement 14AP
2012-07-09REMS · Supplement 12AP
2012-07-09Labeling · Supplement 13AP
2007-01-10Labeling · Supplement 10AP
2000-11-14Manufacturing (CMC) · Supplement 5AP
1998-03-02Manufacturing (CMC) · Supplement 3AP
1995-04-24Manufacturing (CMC) · Supplement 2AP
1994-09-29Manufacturing (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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