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FDA ANDA · ANDA205905

MEMANTINE HYDROCHLORIDE

Sponsor: SUN PHARM

APPLICATION
ANDA205905
TYPE
ANDA
ORIGINAL APPROVAL
2016-09-28
LATEST ACTION
2020-03-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

MEMANTINE HYDROCHLORIDEDiscontinued
MEMANTINE HYDROCHLORIDE 14MG · CAPSULE, EXTENDED RELEASE · ORAL
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

Approval history

2020-03-15Labeling · Supplement 1 · standardAP
2020-03-15Labeling · Supplement 3 · standardAP
2016-09-28UNKNOWN · Original · standard — 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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