APPLICATION
ANDA078720
TYPE
ANDA
ORIGINAL APPROVAL
2008-05-29
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 24 · standardAP
2017-10-30Manufacturing (CMC) · Supplement 13AP
2011-08-01Labeling · Supplement 8AP
2009-03-25Labeling · Supplement 1AP
2008-05-29OriginalAP
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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