ing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201292 07/12/2013
GILOTRIF afatinib tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0597-0138
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
afatinib (afatinib) afatinib 40 mg
Product Characteristics
Color BLUE (Light Blue) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code T40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0597-0138-30 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (0597-0138-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201292 07/12/2013
Labeler -- Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Registrant -- Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Establishment
Name Address ID/FEI Operations
Boehringer Ingelheim Pharma GmbH and Co. KG 551147440 API MANUFACTURE (0597-0137), MANUFACTURE (0597-0141), ANALYSIS (0597-0141), LABEL (0597-0137), LABEL (0597-0138), MANUFACTURE (0597-0137), PACK (0597-0138), ANALYSIS (0597-0138), PACK (0597-0137), API MANUFACTURE (0597-0138), MANUFACTURE (0597-0138), ANALYSIS (0597-0137), PACK (0597-0141), LABEL (0597-0141), API MANUFACTURE (0597-0141)
Establishment
Name Address ID/FEI Operations
Boehringer Ingelheim Roxane Inc 058839929 LABEL (0597-0137), LABEL (0597-0138), PACK (0597-0138), PACK (0597-0137), PACK (0597-0141), LABEL (0597-0141)
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