APPLICATION
ANDA090707
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-30
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued
Products
METHADONE HYDROCHLORIDEPrescription
METHADONE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL
METHADONE HYDROCHLORIDEDiscontinued
METHADONE HYDROCHLORIDE 10MG/5ML · SOLUTION · ORAL
Approval history
2026-06-18REMS · Supplement 36AP
2026-01-22Manufacturing (CMC) · Supplement 33 · unknownAP
2025-12-22Labeling · Supplement 34 · standardAP
2025-09-19Labeling · Supplement 31 · standardAP
2024-10-31REMS · Supplement 32AP
2024-01-03Labeling · Supplement 28 · standardAP
2021-06-02Labeling · Supplement 24 · standardAP
2019-10-11Labeling · Supplement 23 · standardAP
2018-09-21Labeling · Supplement 18 · standardAP
2018-09-18REMS · Supplement 17AP
2018-02-01Labeling · Supplement 16 · standardAP
2018-01-31Labeling · Supplement 15 · standardAP
2018-01-31Labeling · Supplement 14 · standardAP
2017-05-26REMS · Supplement 13AP
2017-01-23Labeling · Supplement 12 · standardAP
2016-12-16Labeling · Supplement 11 · standardAP
2016-12-16Labeling · Supplement 8 · standardAP
2016-12-16Labeling · Supplement 9 · standardAP
2016-09-30REMS · Supplement 10AP
2016-04-20REMS · Supplement 7AP
2015-06-26REMS · Supplement 6AP
2014-08-19REMS · Supplement 5AP
2013-04-15REMS · Supplement 2AP
2012-11-02REMS · 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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