APPLICATION
ANDA090048
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-14
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 5 · standardAP
2016-02-19Labeling · Supplement 2 · 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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