← FDA DRUG APPROVALS

FDA NDA · NDA017058

DISKETS

methadone hydrochloride

Sponsor: HIKMA

APPLICATION
NDA017058
TYPE
NDA
ORIGINAL APPROVAL
1973-03-14
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Prescription

Products

METHADONE HYDROCHLORIDE · ReferencePrescription
METHADONE HYDROCHLORIDE 40MG · TABLET, FOR SUSPENSION · ORAL

Approval history

2025-12-22Labeling · Supplement 29 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 28 · standard — Label ↗AP
2021-06-02Labeling · Supplement 27 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 26 · standard — Label ↗AP
2018-02-01Labeling · Supplement 25 · standard — Label ↗AP
2016-12-16Labeling · Supplement 23 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 22 · standard — Letter ↗AP
2015-08-24Manufacturing (CMC) · Supplement 20 · standardAP
2013-09-19Labeling · Supplement 21 · unknown — Letter ↗AP
2008-02-04Labeling · Supplement 19 · standard — Label ↗AP
2006-12-07Labeling · Supplement 17 · standard — Label ↗AP
2000-09-18Manufacturing (CMC) · Supplement 15 · standardAP
1999-03-30Manufacturing (CMC) · Supplement 14 · standardAP
1998-09-22Manufacturing (CMC) · Supplement 13 · standardAP
1995-09-28Manufacturing (CMC) · Supplement 12 · standardAP
1986-10-31Manufacturing (CMC) · Supplement 8 · standardAP
1986-10-10Manufacturing (CMC) · Supplement 7 · standardAP
1986-01-28Labeling · Supplement 6AP
1985-04-25Manufacturing (CMC) · Supplement 5 · standardAP
1980-03-25Manufacturing (CMC) · Supplement 3 · standardAP
1977-03-25Labeling · Supplement 2AP
1976-05-04Labeling · Supplement 1AP
1973-03-14Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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