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FDA ANDA · ANDA090041

MEMANTINE HYDROCHLORIDE

memantine

Sponsor: AMNEAL PHARMS

APPLICATION
ANDA090041
TYPE
ANDA
ORIGINAL APPROVAL
2015-04-10
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
2015-04-10Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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