APPLICATION
ANDA090635
TYPE
ANDA
ORIGINAL APPROVAL
2009-11-25
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 38AP
2025-12-22Labeling · Supplement 37 · standardAP
2024-10-31REMS · Supplement 34AP
2024-03-08Labeling · Supplement 32 · standardAP
2024-03-08Labeling · Supplement 31 · standardAP
2023-12-04Labeling · Supplement 29 · standardAP
2023-12-04Labeling · Supplement 25 · standardAP
2019-07-16Labeling · Supplement 22 · standardAP
2019-07-16Labeling · Supplement 19 · standardAP
2019-07-16Labeling · Supplement 21 · standardAP
2018-09-18REMS · Supplement 20AP
2017-05-26REMS · Supplement 16AP
2016-09-30REMS · Supplement 14AP
2016-04-20REMS · Supplement 13AP
2015-06-26REMS · Supplement 10AP
2015-06-04Labeling · Supplement 11 · standardAP
2014-08-19REMS · Supplement 9AP
2014-07-23Labeling · Supplement 7 · standardAP
2013-04-15REMS · Supplement 5AP
2012-07-09Labeling · Supplement 4AP
2012-07-09Labeling · Supplement 3AP
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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