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FDA Approval

Galantamine Hydrobromide

Company

Yabao Pharmaceutical Co., Ltd. Beijing (DUNS: 421252976)

Effective Date

May 15, 2015

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Galantamine(4 mg in 1 1)

Manufacturing Establishments (1)

Yabao Pharmaceutical Co., Ltd. Beijing

Labeler

Yabao Pharmaceutical Co., Ltd. Beijing

DUNS Number

421252976

Products (3)

Galantamine Hydrobromide

NDC Product Code

51990-111

Application Number

NDA021169

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

May 28, 2015

Ingredients

GalantamineActive

Code: MJ4PTD2VVWClass: ACTIMQuantity: 4 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

COLLOIDAL SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

STARCH, PREGELATINIZED CORNInactive

Code: O8232NY3SJClass: IACT

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

HYDROXYPROPYL CELLULOSE (TYPE E)Inactive

Code: 66O7AQV0RTClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

Galantamine Hydrobromide

NDC Product Code

51990-112

Application Number

NDA021169

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

May 28, 2015

Ingredients

COLLOIDAL SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

GalantamineActive

Code: MJ4PTD2VVWClass: ACTIMQuantity: 8 mg in 1 1

STARCH, PREGELATINIZED CORNInactive

Code: O8232NY3SJClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

D&C RED NO. 27Inactive

Code: 2LRS185U6KClass: IACT

HYDROXYPROPYL CELLULOSE (TYPE E)Inactive

Code: 66O7AQV0RTClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

Galantamine Hydrobromide

NDC Product Code

51990-113

Application Number

NDA021169

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

May 28, 2015

Ingredients

GalantamineActive

Code: MJ4PTD2VVWClass: ACTIMQuantity: 12 mg in 1 1

COLLOIDAL SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

HYDROXYPROPYL CELLULOSE (TYPE E)Inactive

Code: 66O7AQV0RTClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

STARCH, PREGELATINIZED CORNInactive

Code: O8232NY3SJClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

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