APPLICATION
ANDA040517
TYPE
ANDA
ORIGINAL APPROVAL
2004-04-27
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METHADONE HYDROCHLORIDEPrescription
METHADONE HYDROCHLORIDE 5MG · TABLET · ORAL
METHADONE HYDROCHLORIDEPrescription
METHADONE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 42AP
2025-12-22Labeling · Supplement 38 · standardAP
2025-12-22Labeling · Supplement 40 · standardAP
2024-10-31REMS · Supplement 39AP
2024-01-03Labeling · Supplement 36 · standardAP
2024-01-03Labeling · Supplement 37 · standardAP
2023-12-31Labeling · Supplement 35 · standardAP
2022-03-16Labeling · Supplement 23 · standardAP
2022-03-16Labeling · Supplement 28 · standardAP
2022-03-16Labeling · Supplement 26 · standardAP
2022-03-16Labeling · Supplement 24 · standardAP
2021-06-02Labeling · Supplement 30 · standardAP
2018-09-18REMS · Supplement 25AP
2017-05-26REMS · Supplement 22AP
2016-10-28Labeling · Supplement 19 · standardAP
2016-09-30REMS · Supplement 20AP
2016-04-20REMS · Supplement 18AP
2015-06-26REMS · Supplement 15AP
2015-06-01Labeling · Supplement 16 · standardAP
2014-08-19REMS · Supplement 14AP
2014-07-23Labeling · Supplement 12 · standardAP
2013-04-15REMS · Supplement 9AP
2012-07-09Labeling · Supplement 8AP
2012-07-09REMS · Supplement 7AP
2008-01-26Manufacturing (CMC) · Supplement 4AP
2007-01-10Labeling · Supplement 3AP
2006-03-02Labeling · 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.
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