APPLICATION
ANDA076186
TYPE
ANDA
ORIGINAL APPROVAL
2002-12-16
LATEST ACTION
2025-07-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMANTADINE HYDROCHLORIDEPrescription
AMANTADINE HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2025-07-10Labeling · Supplement 31 · standardAP
2017-12-13Manufacturing (CMC) · Supplement 22 · unknownAP
2012-01-18Labeling · Supplement 18AP
2009-06-04Labeling · Supplement 12AP
2009-02-09Labeling · Supplement 10AP
2007-11-19Labeling · Supplement 9AP
2002-12-16OriginalAP
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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