RAZADYNE
RAZADYNE galantamine HBrTABLETS
Approved
Approval ID
e62efb5a-d2cc-4e11-9e61-10e65ef3d897
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 11, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 2
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 Code21695-591
Application NumberNDA021169
Product Classification
M
Marketing Category
C73594
G
Generic Name
galantamine hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2008
FDA Product Classification
INGREDIENTS (12)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
galantamine hydrobromideActive
Quantity: 12 mg in 1 1
Code: MJ4PTD2VVW
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
galantamine hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-184
Application NumberNDA021169
Product Classification
M
Marketing Category
C73594
G
Generic Name
galantamine hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2008
FDA Product Classification
INGREDIENTS (11)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
galantamine hydrobromideActive
Quantity: 8 mg in 1 1
Code: MJ4PTD2VVW
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT