APPLICATION
ANDA212947
TYPE
ANDA
ORIGINAL APPROVAL
2020-04-03
LATEST ACTION
2024-05-17
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
2024-05-17Manufacturing (CMC) · Supplement 1 · unknownAP
2020-04-03UNKNOWN · 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.
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