APPLICATION
ANDA074170
TYPE
ANDA
ORIGINAL APPROVAL
1994-10-28
LATEST ACTION
2025-07-10
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
AMANTADINE HYDROCHLORIDEPrescription
AMANTADINE HYDROCHLORIDE 50MG/5ML · SYRUP · ORAL
Approval history
2025-07-10Labeling · Supplement 11 · standardAP
2014-06-04Manufacturing (CMC) · Supplement 3AP
2011-06-17Labeling · Supplement 2AP
2009-09-18Labeling · Supplement 1AP
1994-10-28OriginalAP
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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