APPLICATION
ANDA214897
TYPE
ANDA
ORIGINAL APPROVAL
2024-08-26
LATEST ACTION
2024-08-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval), Discontinued
Products
AMANTADINENone (Tentative Approval)
AMANTADINE 137MG · CAPSULE, EXTENDED RELEASE · ORAL
AMANTADINE HYDROCHLORIDEDiscontinued
AMANTADINE HYDROCHLORIDE EQ 68.5MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2024-08-26UNKNOWN · Original · standardTA
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.