APPLICATION
ANDA089897
TYPE
ANDA
ORIGINAL APPROVAL
1988-09-06
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Prescription
Products
METHADONE HYDROCHLORIDE INTENSOLPrescription
METHADONE HYDROCHLORIDE 10MG/ML · CONCENTRATE · ORAL
Approval history
2026-06-18REMS · Supplement 50AP
2024-10-31REMS · Supplement 48AP
2024-05-31Labeling · Supplement 46 · standardAP
2024-05-31Labeling · Supplement 42 · standardAP
2024-05-31Labeling · Supplement 40 · standardAP
2024-05-31Labeling · Supplement 45 · standardAP
2024-05-31Labeling · Supplement 33 · standardAP
2021-04-14Manufacturing (CMC) · Supplement 44 · unknownAP
2018-09-18REMS · Supplement 39AP
2017-06-27Labeling · Supplement 36 · standardAP
2017-05-26REMS · Supplement 38AP
2016-09-30REMS · Supplement 35AP
2016-04-20REMS · Supplement 34AP
2015-06-26REMS · Supplement 32AP
2014-08-19REMS · Supplement 31AP
2013-04-15REMS · Supplement 27AP
2012-07-09REMS · Supplement 26AP
2012-07-09Labeling · Supplement 25 · standardAP
2008-08-27Labeling · Supplement 22AP
2008-01-14Labeling · Supplement 20AP
2008-01-14Labeling · Supplement 21AP
2007-12-12Labeling · Supplement 19AP
2007-05-09Labeling · Supplement 18AP
2001-03-21Manufacturing (CMC) · Supplement 14AP
2000-09-05Manufacturing (CMC) · Supplement 13AP
2000-02-01Manufacturing (CMC) · Supplement 12AP
1999-04-23Manufacturing (CMC) · Supplement 4AP
1999-04-23Manufacturing (CMC) · Supplement 5AP
1999-03-12Manufacturing (CMC) · Supplement 10AP
1999-03-12Manufacturing (CMC) · Supplement 11AP
1997-01-29Manufacturing (CMC) · Supplement 8AP
1997-01-29Manufacturing (CMC) · Supplement 6AP
1997-01-29Labeling · Supplement 7AP
1996-08-28Manufacturing (CMC) · Supplement 9AP
1993-06-15Manufacturing (CMC) · Supplement 2AP
1993-06-15Manufacturing (CMC) · Supplement 3AP
1993-06-15Labeling · Supplement 1AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.