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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022525
Company: ABBVIE

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NAMENDA XR MEMANTINE HYDROCHLORIDE 7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No
NAMENDA XR MEMANTINE HYDROCHLORIDE 14MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No
NAMENDA XR MEMANTINE HYDROCHLORIDE 21MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No
NAMENDA XR MEMANTINE HYDROCHLORIDE 28MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE, EXTENDED RELEASE;ORAL Discontinued None Yes No

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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