← FDA DRUG APPROVALS

FDA NDA · NDA021624

METHADONE HYDROCHLORIDE

Sponsor: MYLAN INSTITUTIONAL

APPLICATION
NDA021624
TYPE
NDA
ORIGINAL APPROVAL
1947-08-13
LATEST ACTION
2025-12-22
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

METHADONE HYDROCHLORIDE · ReferencePrescription
METHADONE HYDROCHLORIDE 10MG/ML · INJECTABLE · INJECTION

Approval history

2025-12-22Labeling · Supplement 18 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 16 · standard — Label ↗AP
2022-05-24Labeling · Supplement 15 · standard — Letter ↗AP
2021-06-02Labeling · Supplement 14 · standard — Label ↗AP
2019-10-07Labeling · Supplement 10 · standard — Label ↗AP
2016-12-16Labeling · Supplement 6 · standard — Letter ↗AP
2013-06-26Manufacturing (CMC) · Supplement 5AP
2004-02-12Labeling · Supplement 1 · standard — Letter ↗AP
1947-08-13UNKNOWN · Original · unknownAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →