Memantine Hydrochloride

Product NDC
47335-321
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090058
Marketing category
ANDA
Substance
MEMANTINE HYDROCHLORIDE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
47335-321-08100 TABLET, FILM COATED in 1 BOTTLE (47335-321-08) 20150711NoHistorical
47335-321-181000 TABLET, FILM COATED in 1 BOTTLE (47335-321-18) 20150711NoHistorical
47335-321-8660 TABLET, FILM COATED in 1 BOTTLE (47335-321-86) 20150711NoHistorical
47335-321-88100 TABLET, FILM COATED in 1 BOTTLE (47335-321-88) 20150711NoHistorical

Related DailyMed Labels

Set IDTitleManufacturerEffective dateTypeVersion
d1963395-3cf7-4433-bf2c-06295bb1c5b0These highlights do not include all the information needed to use memantine hydrochloride tablets safely and effectively. See full prescribing information for memantine hydrochloride tablets. MEMANTINE hydrochloride tablets, for oral use Initial U.S. Approval: 2003Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited2023-10-05Human Prescription Drug Label13