APPLICATION
ANDA075082
TYPE
ANDA
ORIGINAL APPROVAL
1998-03-25
LATEST ACTION
2024-08-27
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Prescription
Products
METHADONE HYDROCHLORIDEPrescription
METHADONE HYDROCHLORIDE 40MG · TABLET, FOR SUSPENSION · ORAL
Approval history
2024-08-27Labeling · Supplement 17 · standardAP
2024-08-27Labeling · Supplement 15 · standardAP
2024-08-27Labeling · Supplement 9 · standardAP
2024-08-27Labeling · Supplement 7 · standardAP
2024-08-27Labeling · Supplement 14 · standardAP
2018-09-18REMS · Supplement 8AP
2015-08-17Labeling · Supplement 6 · standardAP
2007-12-14Labeling · Supplement 5AP
2000-02-02Manufacturing (CMC) · Supplement 2AP
1998-08-25Labeling · 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.
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