nd 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense with a child-resistant closure in a well-closed container.
Keep out of reach of children.
Distributed by:
Caraco Pharmaceutical Laboratories, Ltd.
1150 Elijah McCoy Drive, Detroit, MI 48202
Manufactured by:
Sun Pharmaceutical Industries
Survey No. 259/15,
Dadra-396 191 (U.T. of D & NH)
India.
ISS. 02/2011
PGPI0220
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 8MG
NDC 47335-835-83
Galantamine Hydrobromide Extended-Release Capsules
8 mg
Rx only
30 CAPSULES
SUN PHARMACEUTICAL INDUSTRIES
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 16MG
NDC 47335-836-83
Galantamine Hydrobromide Extended-Release Capsules
16 mg
Rx only
30 CAPSULES
SUN PHARMACEUTICAL INDUSTRIES
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - LABEL - 24MG
NDC 47335-837-83
Galantamine Hydrobromide Extended-Release Capsules
24 mg
Rx only
30 CAPSULES
SUN PHARMACEUTICAL INDUSTRIES
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 47335-835
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GALANTAMINE HYDROBROMIDE (GALANTAMINE) GALANTAMINE 8 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
HYDROXYPROPYL CELLULOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
GELATIN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 835;835
Contains
Packaging
NDC Package Description Multilevel Packaging
1 47335-835-83 30 CAPSULE In 1 BOTTLE None
2 47335-835-88 100 CAPSULE In 1 BOTTLE None
3 47335-835-08 100 CAPSULE In 1 BOTTLE None
4 47335-835-18 1000 CAPSULE In 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090178 02/09/2011
GALANTAMINE HYDROBROMIDE
galantamine hydrobromide capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 47335-836
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GALANTAMINE HYDROBROMIDE (GALANTAMINE) GALANTAMINE 16 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
HYDROXYPROPYL CELLULOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
GELATIN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color PINK (pink opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 836;836
Contains
Pac
