APPLICATION
ANDA087997
TYPE
ANDA
ORIGINAL APPROVAL
1982-08-30
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
METHADONE HYDROCHLORIDE · ReferencePrescription
METHADONE HYDROCHLORIDE 10MG/5ML · SOLUTION · ORAL
Approval history
2026-06-18REMS · Supplement 47AP
2025-12-22Labeling · Supplement 46 · standardAP
2025-12-22Labeling · Supplement 44 · standardAP
2024-10-31REMS · Supplement 45AP
2023-12-15Labeling · Supplement 43 · standardAP
2021-06-02Labeling · Supplement 41 · standardAP
2019-10-09Labeling · Supplement 40 · standardAP
2018-09-21Labeling · Supplement 39 · standardAP
2018-09-18REMS · Supplement 38AP
2018-02-01Labeling · Supplement 37 · standardAP
2018-01-31Labeling · Supplement 36 · standardAP
2017-05-26REMS · Supplement 35AP
2017-03-10Labeling · Supplement 33 · standardAP
2016-12-16Labeling · Supplement 30 · standardAP
2016-12-16Labeling · Supplement 31 · standardAP
2016-12-15Labeling · Supplement 28 · standardAP
2016-09-30REMS · Supplement 32AP
2016-04-20REMS · Supplement 29AP
2015-06-26REMS · Supplement 27AP
2014-08-19REMS · Supplement 26AP
2013-04-15REMS · Supplement 23AP
2012-07-09REMS · Supplement 22AP
2012-07-09Labeling · Supplement 21AP
2008-01-02Labeling · Supplement 19AP
2007-06-07Labeling · Supplement 18AP
2000-02-01Manufacturing (CMC) · Supplement 15AP
1999-03-03Manufacturing (CMC) · Supplement 14AP
1999-03-03Manufacturing (CMC) · Supplement 12AP
1998-03-02Manufacturing (CMC) · Supplement 10AP
1998-03-02Manufacturing (CMC) · Supplement 13AP
1998-03-02Manufacturing (CMC) · Supplement 11AP
1996-08-28Manufacturing (CMC) · Supplement 9AP
1994-01-31Manufacturing (CMC) · Supplement 4AP
1991-12-24Labeling · Supplement 8AP
1991-12-24Labeling · Supplement 5AP
1988-02-04Manufacturing (CMC) · 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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