APPLICATION
NDA022525
TYPE
NDA
ORIGINAL APPROVAL
2010-06-21
LATEST ACTION
2019-11-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
NAMENDA XR · ReferenceDiscontinued
MEMANTINE HYDROCHLORIDE 28MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
NAMENDA XR · ReferenceDiscontinued
MEMANTINE HYDROCHLORIDE 14MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
NAMENDA XR · ReferenceDiscontinued
MEMANTINE HYDROCHLORIDE 21MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
NAMENDA XR · ReferenceDiscontinued
MEMANTINE HYDROCHLORIDE 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2017-01-06Manufacturing (CMC) · Supplement 12 · unknownAP
2016-05-17Manufacturing (CMC) · Supplement 9 · standardAP
2015-05-18Manufacturing (CMC) · Supplement 10 · standardAP
2014-09-09Manufacturing (CMC) · Supplement 7 · standardAP
2013-11-14Manufacturing (CMC) · Supplement 3 · standardAP
2013-06-20Manufacturing (CMC) · 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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