Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022525
Company: FOREST LABS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAMENDA XR MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB 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
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

NAMENDA XR

CAPSULE, EXTENDED RELEASE;ORAL; 7MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205825 AMNEAL PHARMS
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205784 ANCHEN PHARMS
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206135 APOTEX
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206028 LUPIN LTD
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206032 MYLAN
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205905 SUN PHARM
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203293 ZYDUS PHARMS
NAMENDA XR MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 022525 FOREST LABS LLC

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 205784 ANCHEN 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 206028 LUPIN LTD
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206032 MYLAN
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205905 SUN PHARM
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 FOREST LABS LLC

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 205784 ANCHEN 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 206028 LUPIN LTD
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206032 MYLAN
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205905 SUN PHARM
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 FOREST LABS LLC

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 205784 ANCHEN 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 206028 LUPIN LTD
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206032 MYLAN
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205905 SUN PHARM
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 FOREST LABS LLC

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