General MedicationsINTRAMUSCULARStandard
APRETUDE
CABOTEGRAVIR
Standard Dose
600MG/3ML (200MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview APRETUDE is listed in Drugs@FDA under application 215499 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient CABOTEGRAVIR Form and strength SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - 600MG/3ML (200MG/ML) Sponsor VIIV HLTHCARE Submission history Latest submission status date: 2025-04-11 00:00:00.
Structured Monograph
Clinical summary
Approval overview APRETUDE is listed in Drugs@FDA under application 215499 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CABOTEGRAVIR Form and strength SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - 600MG/3ML (200MG/ML) Sponsor VIIV HLTHCARE Submission history Latest submission status date: 2025-04-11 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.