APPLICATION
ANDA088109
TYPE
ANDA
ORIGINAL APPROVAL
1983-03-08
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METHADONE HYDROCHLORIDEPrescription
METHADONE HYDROCHLORIDE 10MG · TABLET · ORAL
METHADONE HYDROCHLORIDEPrescription
METHADONE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 29AP
2025-12-22Labeling · Supplement 26 · standardAP
2025-06-25Labeling · Supplement 23 · standardAP
2024-10-31REMS · Supplement 24AP
2023-12-15Labeling · Supplement 22 · standardAP
2021-06-02Labeling · Supplement 21 · standardAP
2020-05-05REMS · Supplement 20AP
1998-04-01Manufacturing (CMC) · Supplement 17AP
1998-04-01Manufacturing (CMC) · Supplement 11AP
1998-04-01Manufacturing (CMC) · Supplement 18AP
1998-04-01Manufacturing (CMC) · Supplement 12AP
1996-08-28Manufacturing (CMC) · Supplement 15AP
1996-08-27Manufacturing (CMC) · Supplement 16AP
1995-08-25Manufacturing (CMC) · Supplement 14AP
1995-05-19Labeling · Supplement 13AP
1992-05-12Labeling · Supplement 10AP
1991-07-31Manufacturing (CMC) · Supplement 9AP
1990-02-26Labeling · Supplement 7AP
1988-09-02Manufacturing (CMC) · Supplement 4AP
1988-09-02Manufacturing (CMC) · Supplement 5AP
1988-09-02Bioequivalence · Supplement 1AP
1987-10-21Labeling · 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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