APPLICATION
ANDA212044
TYPE
ANDA
ORIGINAL APPROVAL
2020-05-21
LATEST ACTION
2025-07-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
AMANTADINE HYDROCHLORIDEPrescription
AMANTADINE HYDROCHLORIDE 100MG · CAPSULE · ORAL
Approval history
2025-07-10Labeling · Supplement 7 · standardAP
2020-05-21UNKNOWN · 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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