APPLICATION
ANDA210215
TYPE
ANDA
ORIGINAL APPROVAL
2020-03-10
LATEST ACTION
2026-05-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMANTADINE HYDROCHLORIDEPrescription
AMANTADINE HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2026-05-13Labeling · Supplement 1 · standardAP
2020-03-10UNKNOWN · 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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