SYNJARDYXR(empagliflozin and metformin hydrochloride extended-release) tablets(四十一)
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PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0597-0295-61 1 in 1 CARTON 12/10/2016
1 7 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:0597-0295-78 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/10/2016
3 NDC:0597-0295-88 30 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:0597-0300
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
Empagliflozin (UNII: HDC1R2M35U) (Empagliflozin - UNII:HDC1R2M35U) Empagliflozin 12.5 mg
Metformin Hydrochloride (UNII: 786Z46389E) (Metformin - UNII:9100L32L2N) Metformin Hydrochloride 1000 mg
PRODUCT CHARACTERISTICS
Color BLUE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code S12;1000
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0597-0300-20 1 in 1 CARTON 12/10/2016
1 14 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:0597-0300-45 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/10/2016
3 NDC:0597-0300-93 180 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
LABELER - BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. (603175944)
REGISTRANT - BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. (603175944)
ESTABLISHMENT
Name Address ID/FEI Business Operations
PATHEON PHARMACEUTICALS INC. 005286822 manufacture(0597-0280, 0597-0290, 0597-0295, 0597-0300) , analysis(0597-0280, 0597-0290, 0597-0295, 0597-0300) , label(0597-0280, 0597-0290, 0597-0295, 0597-0300) , pack(0597-0280, 0597-0290, 0597-0295, 0597-0300)
ESTABLISHMENT
Name Address ID/FEI Business Operations
Sixarp, LLC 016329513 pack(0597-0280, 0597-0290, 0597-0295, 0597-0300) |
