kaging
NDC Package Description Multilevel Packaging
1 47335-836-83 30 CAPSULE In 1 BOTTLE None
2 47335-836-88 100 CAPSULE In 1 BOTTLE None
3 47335-836-08 100 CAPSULE In 1 BOTTLE None
4 47335-836-18 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) 47335-837
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GALANTAMINE HYDROBROMIDE (GALANTAMINE) GALANTAMINE 24 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
HYDROXYPROPYL CELLULOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
GELATIN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FD&C YELLOW NO. 6
Product Characteristics
Color BROWN (caramel opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 837;837
Contains
Packaging
NDC Package Description Multilevel Packaging
1 47335-837-83 30 CAPSULE In 1 BOTTLE None
2 47335-837-88 100 CAPSULE In 1 BOTTLE None
3 47335-837-08 100 CAPSULE In 1 BOTTLE None
4 47335-837-18 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
Labeler - Sun Pharma Global FZE (864347344)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries 650445203 MANUFACTURE, ANALYSIS
Revised: 02/2011Sun Pharma Global FZE
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