Galantamine hydrobromide
Galantamine Hydrobromide Extended-release Capsules
Approved
Approval ID
9a04069a-02e2-4428-a73f-51e58b51af89
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 13, 2016
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Galantamine hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-984
Application NumberANDA079028
Product Classification
M
Marketing Category
C73584
G
Generic Name
Galantamine hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2014
FDA Product Classification
INGREDIENTS (7)
GALANTAMINE HYDROBROMIDEActive
Quantity: 16 mg in 1 1
Code: MJ4PTD2VVW
Classification: ACTIM
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT