APPLICATION
ANDA077659
TYPE
ANDA
ORIGINAL APPROVAL
2006-02-23
LATEST ACTION
2025-07-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
AMANTADINE HYDROCHLORIDEDiscontinued
AMANTADINE HYDROCHLORIDE 100MG · CAPSULE · ORAL
Approval history
2025-07-10Labeling · Supplement 3 · standardAP
2016-11-27Labeling · Supplement 2AP
2006-02-23OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.