APPLICATION
ANDA087393
TYPE
ANDA
ORIGINAL APPROVAL
1981-05-22
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
METHADONE HYDROCHLORIDE · ReferencePrescription
METHADONE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL
Approval history
2026-06-18REMS · Supplement 55AP
2025-12-22Labeling · Supplement 54 · standardAP
2025-12-22Labeling · Supplement 52 · standardAP
2024-10-31REMS · Supplement 53AP
2023-12-15Labeling · Supplement 51 · standardAP
2021-06-02Labeling · Supplement 49 · standardAP
2019-10-09Labeling · Supplement 48 · standardAP
2018-09-21Labeling · Supplement 47 · standardAP
2018-09-18REMS · Supplement 46AP
2018-02-01Labeling · Supplement 45 · standardAP
2018-01-31Labeling · Supplement 44 · standardAP
2017-05-26REMS · Supplement 43AP
2016-12-16Labeling · Supplement 39 · standardAP
2016-12-16Labeling · Supplement 40 · standardAP
2016-12-15Labeling · Supplement 37 · standardAP
2016-09-30REMS · Supplement 41AP
2016-04-20REMS · Supplement 38AP
2015-06-26REMS · Supplement 36AP
2014-08-19REMS · Supplement 35AP
2013-04-15REMS · Supplement 32AP
2012-07-09Labeling · Supplement 30AP
2012-07-09REMS · Supplement 31AP
2008-01-02Labeling · Supplement 28AP
2007-06-07Labeling · Supplement 27AP
1999-11-17Manufacturing (CMC) · Supplement 23AP
1999-11-17Manufacturing (CMC) · Supplement 24AP
1999-02-17Manufacturing (CMC) · Supplement 22AP
1999-02-17Manufacturing (CMC) · Supplement 18AP
1998-03-09Manufacturing (CMC) · Supplement 20AP
1998-03-09Manufacturing (CMC) · Supplement 19AP
1998-03-09Manufacturing (CMC) · Supplement 21AP
1996-08-28Manufacturing (CMC) · Supplement 17AP
1991-07-17Manufacturing (CMC) · Supplement 9AP
1991-05-10Labeling · Supplement 16AP
1991-04-02Labeling · Supplement 14AP
1988-02-23Manufacturing (CMC) · Supplement 8AP
1987-11-04Manufacturing (CMC) · Supplement 5AP
1987-11-04Manufacturing (CMC) · Supplement 3AP
1987-11-04Manufacturing (CMC) · Supplement 4AP
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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