APPLICATION
ANDA075060
TYPE
ANDA
ORIGINAL APPROVAL
1998-12-24
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 13 · standardAP
2024-10-24Manufacturing (CMC) · Supplement 12 · unknownAP
2011-08-31Labeling · Supplement 5AP
2007-09-14Labeling · Supplement 3AP
2007-01-12Labeling · Supplement 2AP
2001-08-15Manufacturing (CMC) · 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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