Gilotrif
These highlights do not include all the information needed to use GILOTRIF safely and effectively. See full prescribing information for GILOTRIF. GILOTRIF (afatinib tablets), for oral use Initial U.S. Approval: 2013
Approved
Approval ID
fd638e5e-8032-e7ca-0179-95e96ab5d387
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 11, 2022
Manufacturers
FDA
Boehringer Ingelheim Pharmaceuticals, Inc.
DUNS: 603175944
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
afatinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0597-0141
Application NumberNDA201292
Product Classification
M
Marketing Category
C73594
G
Generic Name
afatinib
Product Specifications
Route of AdministrationORAL
Effective DateApril 13, 2022
FDA Product Classification
INGREDIENTS (1)
AFATINIBActive
Quantity: 20 mg in 1 1
Code: 41UD74L59M
Classification: ACTIB
afatinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0597-0137
Application NumberNDA201292
Product Classification
M
Marketing Category
C73594
G
Generic Name
afatinib
Product Specifications
Route of AdministrationORAL
Effective DateApril 13, 2022
FDA Product Classification
INGREDIENTS (1)
AFATINIBActive
Quantity: 30 mg in 1 1
Code: 41UD74L59M
Classification: ACTIB
afatinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0597-0138
Application NumberNDA201292
Product Classification
M
Marketing Category
C73594
G
Generic Name
afatinib
Product Specifications
Route of AdministrationORAL
Effective DateApril 13, 2022
FDA Product Classification
INGREDIENTS (1)
AFATINIBActive
Quantity: 40 mg in 1 1
Code: 41UD74L59M
Classification: ACTIB