APPLICATION
ANDA214284
TYPE
ANDA
ORIGINAL APPROVAL
2020-10-15
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 6 · standardAP
2020-10-15UNKNOWN · Original · standardAP
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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