BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202343 10/07/2011
JUVISYNC
sitagliptin and simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-0757
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SITAGLIPTIN PHOSPHATE (SITAGLIPTIN) SITAGLIPTIN 100 mg
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
SODIUM STEARYL FUMARATE
MAGNESIUM STEARATE
ASCORBIC ACID
CITRIC ACID MONOHYDRATE
LACTOSE MONOHYDRATE
STARCH, CORN
POLYVINYL ALCOHOL
POLYETHYLENE GLYCOL 3350
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
BUTYLATED HYDROXYANISOLE
Product Characteristics
Color PINK (PINK-BEIGE) Score no score
Shape OVAL (MODIFIED CAPSULE-SHAPED) Size 16mm
Flavor Imprint Code 757
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-0757-31 30 TABLET, FILM COATED ( TABLET) in 1 BOTTLE None
2 NDC:0006-0757-54 90 TABLET, FILM COATED ( TABLET) in 1 BOTTLE None
3 NDC:0006-0757-82 1000 TABLET, FILM COATED ( TABLET) in 1 BOTTLE None
4 NDC:0006-0757-14 2 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE (0006-0757-07)
4 NDC:0006-0757-07 7 TABLET, FILM COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (0006-0757-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202343 10/07/2011
JUVISYNC
sitagliptin and simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-0773
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SITAGLIPTIN PHOSPHATE (SITAGLIPTIN) SITAGLIPTIN 100 mg
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
SODIUM STEARYL FUMARATE
MAGNESIUM STEARATE
ASCORBIC ACID
CITRIC ACID MONOHYDRATE
LACTOSE MONOHYDRATE
STARCH, CORN
POLYVINYL ALCOHOL
POLYETHYLENE GLYCOL 3350
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
BUTYLATED HYDROXYANISOLE
Product Characteristics
Color ORANGE (ORANGE-BEIGE) |
