APPLICATION
ANDA204166
TYPE
ANDA
ORIGINAL APPROVAL
2020-03-16
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METHADONE HYDROCHLORIDEPrescription
METHADONE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 11AP
2025-12-23Labeling · Supplement 10 · standardAP
2025-03-27Labeling · Supplement 5 · standardAP
2024-10-31REMS · Supplement 6AP
2023-12-15Labeling · Supplement 4 · standardAP
2023-09-27Labeling · Supplement 2 · standardAP
2021-06-02Labeling · Supplement 1 · standardAP
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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