Tradjenta(linagliptin)tablets - America[美国药品]

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Tradjenta(linagliptin)tablets(十七)

2013-11-02 18:39:38 来源: 作者: 【大中小】浏览:7823次评论:0条

/01
Revised May 2011
TRADJENTA (linagliptin) 30 Tablets
NDC: 0597-0140-30

TRADJENTA (linagliptin) 1000 Tablets
NDC: 0597-0140-10

TRADJENTA (linagliptin) 7 Tablets
v NDC: 0597-0140-70

TRADJENTA (linagliptin) 90 Tablets
NDC: 0597-0140-90

TRADJENTA
linagliptin   tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0597-0140
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
linagliptin (linagliptin) linagliptin 5 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
STARCH, CORN
COPOVIDONE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (5 MPA.S)
TITANIUM DIOXIDE
TALC
POLYETHYLENE GLYCOL 6000
FERRIC OXIDE RED
Product Characteristics
Color RED (Light Red) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code D5;
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0597-0140-30 30 In 1 BOTTLE None
2 0597-0140-90 90 In 1 BOTTLE None
3 0597-0140-10 1000 In 1 BOTTLE None
4 0597-0140-70 1 In 1 CARTON contains a BLISTER PACK
4 7 In 1 BLISTER PACK This package is contained within the CARTON (0597-0140-70)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201280 05/09/2011
Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Registrant - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
Establishment
Name Address ID/FEI Operations
Boehringer Ingelheim Pharma GmbH & Co. KG 551147440 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Boehringer Ingelheim Roxane Inc. 058839929 MANUFACTURE
Revised: 05/2011Boehringer Ingelheim Pharmaceuticals, Inc.