MEMANTINE
These highlights do not include all the information needed to use MEMANTINE HYDROCHLORIDE oral solution safely and effectively. See full prescribing information for MEMANTINE HYDROCHLORIDE oral solution. MEMANTINE HYDROCHLORIDE solution, for oral use Initial U.S. Approval: 2003
Approved
Approval ID
4076d3ef-d0a9-96c5-1a15-812c1e42929c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2023
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
memantine hydrochloride
PRODUCT DETAILS
NDC Product Code60505-6162
Application NumberANDA209955
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 14, 2023
Generic Namememantine hydrochloride
INGREDIENTS (9)
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
MEMANTINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: JY0WD0UA60
Classification: ACTIB