Apretude
These highlights do not include all the information needed to use APRETUDE safely and effectively. See full prescribing information for APRETUDE. APRETUDE (cabotegravir extended-release injectable suspension), for intramuscular useInitial U.S. Approval: 2021
Approved
Approval ID
4338428e-43d4-4e02-ac9d-bd98e738a7da
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49702-280
Application NumberNDA215499
Product Classification
M
Marketing Category
C73594
G
Generic Name
Cabotegravir
Product Specifications
Effective DateDecember 13, 2023
FDA Product Classification
Cabotegravir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49702-264
Application NumberNDA215499
Product Classification
M
Marketing Category
C73594
G
Generic Name
Cabotegravir
Product Specifications
Effective DateDecember 13, 2023
FDA Product Classification
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 9/20/2024
Boxed Warning section
LOINC: 34066-1Updated: 9/20/2024
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 9/20/2024
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 9/20/2024
WARNINGS AND PRECAUTIONS SECTION
LOINC: 43685-7Updated: 9/20/2024
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 9/20/2024
DRUG INTERACTIONS SECTION
LOINC: 34073-7Updated: 9/20/2024
DESCRIPTION SECTION
LOINC: 34089-3Updated: 9/20/2024
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 2/27/2023
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 9/20/2024
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 9/20/2024
DOSAGE FORMS & STRENGTHS SECTION
LOINC: 43678-2Updated: 9/20/2024
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 2/27/2023
INFORMATION FOR PATIENTS SECTION
LOINC: 34076-0Updated: 9/20/2024
SPL PATIENT PACKAGE INSERT SECTION
LOINC: 42230-3Updated: 9/20/2024
INSTRUCTIONS FOR USE SECTION
LOINC: 59845-8Updated: 9/20/2024
USE IN SPECIFIC POPULATIONS SECTION
LOINC: 43684-0Updated: 9/20/2024
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 9/20/2024
NONCLINICAL TOXICOLOGY SECTION
LOINC: 43680-8Updated: 2/27/2023
CLINICAL STUDIES SECTION
LOINC: 34092-7Updated: 9/20/2024