Memantine Hydrochloride
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 Oral Solution, for oral use Initial U.S. Approval: 2003
Approved
Approval ID
a7b76864-6de7-45f6-be5b-5ecfca811627
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 12, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-943
Application NumberANDA204033
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 12, 2023
Generic NameMemantine Hydrochloride
INGREDIENTS (9)
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MEMANTINE HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: JY0WD0UA60
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT