NDC Code(s) : 0378-8105-93, 0378-8106-93, 0378-8107-93
Packager : Mylan Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Galantamine Hydrobromidegalantamine hydrobromide CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8105
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GALANTAMINE HYDROBROMIDE(UNII: MJ4PTD2VVW)
(GALANTAMINE - UNII:0D3Q044KCA) 		GALANTAMINE8 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
AMMONIA(UNII: 5138Q19F1X)
Product Characteristics
Color PINK (pink opaque), WHITE (white opaque) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code MYLAN;GT;8
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-8105-9330 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product24/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090900 01/24/2011 04/30/2013
Galantamine Hydrobromidegalantamine hydrobromide CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8106
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GALANTAMINE HYDROBROMIDE(UNII: MJ4PTD2VVW)
(GALANTAMINE - UNII:0D3Q044KCA) 		GALANTAMINE16 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
AMMONIA(UNII: 5138Q19F1X)
Product Characteristics
Color PINK (pale pink opaque), WHITE (white opaque) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code MYLAN;GT;16
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-8106-9330 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product24/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090900 01/24/2011 04/30/2013
Galantamine Hydrobromidegalantamine hydrobromide CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8107
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GALANTAMINE HYDROBROMIDE(UNII: MJ4PTD2VVW)
(GALANTAMINE - UNII:0D3Q044KCA) 		GALANTAMINE24 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
AMMONIA(UNII: 5138Q19F1X)
Product Characteristics
Color PINK (pink opaque), WHITE (white opaque) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code MYLAN;GT;24
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-8107-9330 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product24/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090900 01/24/2011 10/31/2013

PRINCIPAL DISPLAY PANEL

NDC 0378-8105-93

Galantamine
Extended-Release
Capsules, USP
8 mg

Rx only      30 Capsules

Each capsule contains:
galantamine hydrobromide, USP
equivalent to 8 mg of galantamine.

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F ).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying
prescribing information.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in Australia

Mylan.com

RALP8105H3

Galantamine Extended-Release Capsules, USP 8 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 0378-8106-93

Galantamine
Extended-Release
Capsules, USP
16 mg

Rx only      30 Capsules

Each capsule contains:
galantamine hydrobromide, USP
equivalent to 16 mg of galantamine.

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F ).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying
prescribing information.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in Australia

Mylan.com

RALP8106H3

Galantamine Extended-Release Capsules, USP 16 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 0378-8107-93

Galantamine
Extended-Release
Capsules, USP
24 mg

Rx only      30 Capsules

Each capsule contains:
galantamine hydrobromide, USP
equivalent to 24 mg of galantamine.

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F ).
[See USP Controlled Room
Temperature.]

Usual Dosage: See accompanying
prescribing information.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in Australia

Mylan.com

RALP8107H3

Galantamine Extended-Release Capsules, USP 24 mg Bottle Label