APPLICATION
ANDA206032
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-28
LATEST ACTION
2025-04-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
MEMANTINE HYDROCHLORIDEPrescription
MEMANTINE HYDROCHLORIDE 21MG · CAPSULE, EXTENDED RELEASE · ORAL
MEMANTINE HYDROCHLORIDEPrescription
MEMANTINE HYDROCHLORIDE 7MG · CAPSULE, EXTENDED RELEASE · ORAL
MEMANTINE HYDROCHLORIDEPrescription
MEMANTINE HYDROCHLORIDE 28MG · CAPSULE, EXTENDED RELEASE · ORAL
MEMANTINE HYDROCHLORIDEPrescription
MEMANTINE HYDROCHLORIDE 14MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2025-04-18Manufacturing (CMC) · Supplement 6 · unknownAP
2020-03-15Labeling · Supplement 1 · standardAP
2020-03-15Labeling · Supplement 4 · 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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