EXKIVITY
These highlights do not include all the information needed to use EXKIVITY safely and effectively. See full prescribing information for EXKIVITY. EXKIVITY (mobocertinib) capsules, for oral use Initial U.S. Approval: 2021
Approved
Approval ID
f1a91500-a944-4cb8-b4a8-ae278bcf728d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 15, 2023
Manufacturers
FDA
Takeda Pharmaceuticals America, Inc.
DUNS: 039997266
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mobocertinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63020-040
Application NumberNDA215310
Product Classification
M
Marketing Category
C73594
G
Generic Name
Mobocertinib
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2023
FDA Product Classification
INGREDIENTS (1)
MobocertinibActive
Quantity: 40 mg in 1 1
Code: 39HBQ4A67L
Classification: ACTIB