SYNJARDYXR(empagliflozin and metformin hydrochloride extended-release) tablets(四十)
bsp;ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
Empagliflozin (UNII: HDC1R2M35U) (Empagliflozin - UNII:HDC1R2M35U) Empagliflozin 10 mg
Metformin Hydrochloride (UNII: 786Z46389E) (Metformin - UNII:9100L32L2N) Metformin Hydrochloride 1000 mg
PRODUCT CHARACTERISTICS
Color ORANGE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code S10;1000
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0597-0280-36 1 in 1 CARTON 12/10/2016
1 7 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:0597-0280-73 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/10/2016
3 NDC:0597-0280-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/10/2016
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208658 12/10/2016
SYNJARDY XR
empagliflozin, metformin hydrochloride tablet, extended release
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0597-0290
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
Empagliflozin (UNII: HDC1R2M35U) (Empagliflozin - UNII:HDC1R2M35U) Empagliflozin 5 mg
Metformin Hydrochloride (UNII: 786Z46389E) (Metformin - UNII:9100L32L2N) Metformin Hydrochloride 1000 mg
PRODUCT CHARACTERISTICS
Color GREEN Score no score
Shape OVAL Size 19mm
Flavor Imprint Code S5;1000
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0597-0290-20 1 in 1 CARTON 12/10/2016
1 14 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:0597-0290-59 180 in 1 BOTTLE; Type 0: Not a Combination Product 12/10/2016
3 NDC:0597-0290-74 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/10/2016
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208658 12/10/2016
SYNJARDY XR
empagliflozin, metformin hydrochloride tablet, extended release
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0597-0295
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
Empagliflozin (UNII: HDC1R2M35U) (Empagliflozin - UNII:HDC1R2M35U) Empagliflozin 25 mg
Metformin Hydrochloride (UNII: 786Z46389E) (Metformin - UNII:9100L32L2N) Metformin Hydrochloride 1000 mg
PRODUCT CHARACTERISTICS
Color GREEN (light green) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code S25;1000
Contains & |
