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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022525
Company: ABBVIE

Summary Review

Products on NDA 022525

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAMENDA XR	MEMANTINE HYDROCHLORIDE	7MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
NAMENDA XR	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
NAMENDA XR	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
NAMENDA XR	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022525

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/21/2010	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022525s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022525s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022525s000_namenda_xr_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022525Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2019	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022525s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022525Orig1s015ltr.pdf
01/06/2017	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
05/18/2015	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/17/2016	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/09/2014	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/26/2014	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022525s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022525Orig1s006ltr.pdf
07/03/2014	SUPPL-5	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022525s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022525Orig1s005ltr.pdf
11/14/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/20/2013	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022525

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2019	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022525s015lbl.pdf
09/26/2014	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022525s006lbl.pdf
07/03/2014	SUPPL-5	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022525s005lbl.pdf
06/21/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022525s000lbl.pdf

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