Cabenuva
These highlights do not include all the information needed to use CABENUVA safely and effectively. See full prescribing information for CABENUVA.CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension), co-packaged for intramuscular useInitial U.S. Approval: 2021
Approved
Approval ID
1698baf3-f895-4c42-a1b1-e9ee3f20da36
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2023
Manufacturers
FDA
ViiV Healthcare Company
DUNS: 027295585
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cabotegravir and rilpivirine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49702-240
Application NumberNDA212888
Product Classification
M
Marketing Category
C73594
G
Generic Name
cabotegravir and rilpivirine
Product Specifications
Effective DateDecember 13, 2023
FDA Product Classification
cabotegravir and rilpivirine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49702-253
Application NumberNDA212888
Product Classification
M
Marketing Category
C73594
G
Generic Name
cabotegravir and rilpivirine
Product Specifications
Effective DateDecember 13, 2023
FDA Product Classification