APPLICATION
ANDA208096
TYPE
ANDA
ORIGINAL APPROVAL
2016-12-15
LATEST ACTION
2025-07-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AMANTADINE HYDROCHLORIDEDiscontinued
AMANTADINE HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2025-07-10Labeling · Supplement 4 · standardAP
2016-12-15UNKNOWN · 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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