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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206439
Company: ABBVIE

Summary Review

Products on NDA 206439

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAMZARIC	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
NAMZARIC	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes
NAMZARIC	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;7MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
NAMZARIC	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206439

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/2014	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206439lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206439Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206439Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206439Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2016	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206439s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206439Orig1s003ltr.pdf
10/06/2015	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/01/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 206439

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2016	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206439s003lbl.pdf
12/23/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206439lbl.pdf

Therapeutic Equivalents for NDA 206439

NAMZARIC

CAPSULE, EXTENDED RELEASE;ORAL; 10MG;21MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	208237	ANI PHARMS
NAMZARIC	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;21MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	206439	ABBVIE

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