APPLICATION
ANDA210484
TYPE
ANDA
ORIGINAL APPROVAL
2018-08-02
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 12AP
2025-12-22Labeling · Supplement 11 · standardAP
2025-12-22Labeling · Supplement 9 · standardAP
2024-10-31REMS · Supplement 10AP
2023-12-15Labeling · Supplement 7 · standardAP
2023-12-15Labeling · Supplement 8 · standardAP
2021-06-02Labeling · Supplement 6 · standardAP
2021-02-16Labeling · Supplement 5 · standardAP
2021-02-16Labeling · Supplement 2 · standardAP
2018-09-18REMS · 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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