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FDA ANDA · ANDA074184

METHADOSE DISPERSIBLE

methadone hydrochloride

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APPLICATION
ANDA074184
TYPE
ANDA
ORIGINAL APPROVAL
1993-04-29
LATEST ACTION
2018-09-18
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Prescription

Products

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

Approval history

2018-09-18REMS · Supplement 22AP
2014-12-13Labeling · Supplement 16 · standardAP
2009-11-09Labeling · Supplement 12AP
2007-04-04Labeling · Supplement 11AP
2006-03-23Labeling · Supplement 10AP
2000-11-28Manufacturing (CMC) · Supplement 4AP
1995-11-21Manufacturing (CMC) · Supplement 2AP
1994-09-29Manufacturing (CMC) · Supplement 1AP
1993-04-29Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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