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FDA ANDA · ANDA090044

MEMANTINE HYDROCHLORIDE

Sponsor: ORBION PHARMS

APPLICATION
ANDA090044
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-12
LATEST ACTION
2021-01-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MEMANTINE HYDROCHLORIDEDiscontinued
MEMANTINE HYDROCHLORIDE 5MG · TABLET · ORAL
MEMANTINE HYDROCHLORIDEDiscontinued
MEMANTINE HYDROCHLORIDE 10MG · TABLET · ORAL

Approval history

2021-01-21Labeling · Supplement 2 · standardAP
2016-01-06Labeling · Supplement 1 · standardAP
2012-03-12Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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