APPLICATION
ANDA203502
TYPE
ANDA
ORIGINAL APPROVAL
2015-08-31
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 14AP
2025-12-22Labeling · Supplement 13 · standardAP
2024-10-31REMS · Supplement 12AP
2024-03-19Labeling · Supplement 11 · standardAP
2024-03-18Labeling · Supplement 10 · standardAP
2024-03-18Labeling · Supplement 9 · standardAP
2021-06-02Labeling · Supplement 8 · standardAP
2021-02-18Labeling · Supplement 7 · standardAP
2021-02-18Labeling · Supplement 4 · standardAP
2018-09-18REMS · Supplement 5AP
2017-05-26REMS · Supplement 3AP
2016-09-30REMS · Supplement 2AP
2016-04-20REMS · 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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