APPLICATION
ANDA206855
TYPE
ANDA
ORIGINAL APPROVAL
2015-11-17
LATEST ACTION
2019-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MEMANTINE HYDROCHLORIDEPrescription
MEMANTINE HYDROCHLORIDE 5MG · TABLET · ORAL
MEMANTINE HYDROCHLORIDEPrescription
MEMANTINE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2019-06-28Labeling · Supplement 1 · standardAP
2015-11-17UNKNOWN · 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.
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.