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FDA NDA · NDA215499

APRETUDE

cabotegravir

Sponsor: VIIV HLTHCARE

APPLICATION
NDA215499
TYPE
NDA
ORIGINAL APPROVAL
2021-12-20
LATEST ACTION
2025-04-11
ROUTE
INTRAMUSCULAR
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

APRETUDE · ReferencePrescription
CABOTEGRAVIR 600MG/3ML (200MG/ML) · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR

Approval history

2025-04-11Labeling · Supplement 9 · standard — Letter ↗AP
2024-09-20Efficacy · Supplement 8 · standard — Letter ↗AP
2023-12-13Labeling · Supplement 4 · standard — Letter ↗AP
2023-02-27Labeling · Supplement 2 · standard — Label ↗AP
2021-12-20Type 5 - New Formulation or New Manufacturer · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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