APPLICATION
ANDA076352
TYPE
ANDA
ORIGINAL APPROVAL
2004-09-10
LATEST ACTION
2025-07-10
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued
Products
AMANTADINE HYDROCHLORIDEDiscontinued
AMANTADINE HYDROCHLORIDE 50MG/5ML · SYRUP · ORAL
Approval history
2025-07-10Labeling · Supplement 3 · standardAP
2011-08-01Labeling · Supplement 1AP
2004-09-10OriginalAP
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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