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FDA ANDA · ANDA206135

MEMANTINE HYDROCHLORIDE

Sponsor: APOTEX

APPLICATION
ANDA206135
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-22
LATEST ACTION
2020-08-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

MEMANTINE HYDROCHLORIDEDiscontinued
MEMANTINE HYDROCHLORIDE 21MG · CAPSULE, EXTENDED RELEASE · ORAL
MEMANTINE HYDROCHLORIDEDiscontinued
MEMANTINE HYDROCHLORIDE 7MG · CAPSULE, EXTENDED RELEASE · ORAL
MEMANTINE HYDROCHLORIDEDiscontinued
MEMANTINE HYDROCHLORIDE 28MG · CAPSULE, EXTENDED RELEASE · ORAL
MEMANTINE HYDROCHLORIDEDiscontinued
MEMANTINE HYDROCHLORIDE 14MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2020-08-13Labeling · Supplement 1 · standardAP
2016-11-22UNKNOWN · Original · standardAP
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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