APPLICATION
ANDA207537
TYPE
ANDA
ORIGINAL APPROVAL
2019-10-02
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
METHADONE HYDROCHLORIDEPrescription
METHADONE HYDROCHLORIDE 10MG/5ML · SOLUTION · ORAL
METHADONE HYDROCHLORIDEPrescription
METHADONE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL
Approval history
2026-06-18REMS · Supplement 16AP
2025-12-22Labeling · Supplement 14 · standardAP
2025-12-22Labeling · Supplement 10 · standardAP
2024-10-31REMS · Supplement 11AP
2024-01-03Labeling · Supplement 9 · standardAP
2024-01-03Labeling · Supplement 8 · standardAP
2021-06-02Labeling · Supplement 3 · standardAP
2021-03-04Labeling · Supplement 2 · standardAP
2021-02-08Labeling · 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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