Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 206439
Company: FOREST LABS LLC
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 AB Yes No
NAMZARIC DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE 10MG;28MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB 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 None Yes No
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.

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

NAMZARIC

CAPSULE, EXTENDED RELEASE;ORAL; 10MG;14MG
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;14MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 208328 AMNEAL PHARMS
NAMZARIC DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE 10MG;14MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 206439 FOREST LABS LLC

CAPSULE, EXTENDED RELEASE;ORAL; 10MG;28MG
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;28MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 208328 AMNEAL PHARMS
NAMZARIC DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE 10MG;28MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 206439 FOREST LABS LLC

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