An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
NAMENDA XR	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No
NAMENDA XR	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No
NAMENDA XR	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	Yes

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

Therapeutic Equivalents for NDA 022525

NAMENDA XR

CAPSULE, EXTENDED RELEASE;ORAL; 14MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	205825	AMNEAL PHARMS
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	206135	APOTEX
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	214651	AUROBINDO PHARMA LTD
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	206028	LUPIN LTD
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	213985	XIAMEN LP PHARM CO
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	211100	YICHANG HUMANWELL
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	203293	ZYDUS PHARMS
NAMENDA XR	MEMANTINE HYDROCHLORIDE	14MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022525	ABBVIE

CAPSULE, EXTENDED RELEASE;ORAL; 21MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	205825	AMNEAL PHARMS
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	206135	APOTEX
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	214651	AUROBINDO PHARMA LTD
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	206028	LUPIN LTD
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	213985	XIAMEN LP PHARM CO
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	211100	YICHANG HUMANWELL
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	203293	ZYDUS PHARMS
NAMENDA XR	MEMANTINE HYDROCHLORIDE	21MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022525	ABBVIE

CAPSULE, EXTENDED RELEASE;ORAL; 28MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	205825	AMNEAL PHARMS
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	206135	APOTEX
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	214651	AUROBINDO PHARMA LTD
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	206028	LUPIN LTD
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	213985	XIAMEN LP PHARM CO
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	211100	YICHANG HUMANWELL
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	203293	ZYDUS PHARMS
NAMENDA XR	MEMANTINE HYDROCHLORIDE	28MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022525	ABBVIE

Top