APPLICATION
ANDA077142
TYPE
ANDA
ORIGINAL APPROVAL
2005-07-12
LATEST ACTION
2018-09-18
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Prescription
Products
METHADONE HYDROCHLORIDEPrescription
METHADONE HYDROCHLORIDE 40MG · TABLET, FOR SUSPENSION · ORAL
Approval history
2018-09-18REMS · Supplement 17AP
2014-12-13Labeling · Supplement 11 · standardAP
2014-11-05Manufacturing (CMC) · Supplement 8AP
2009-11-09Labeling · Supplement 6AP
2007-04-04Labeling · Supplement 5AP
2006-09-20Labeling · Supplement 2AP
2006-03-23Labeling · Supplement 3AP
2005-07-12OriginalAP
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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