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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215499
Company: VIIV HLTHCARE

Products on NDA 215499

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
APRETUDE	CABOTEGRAVIR	600MG/3ML (200MG/ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215499

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2021	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215499s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215499Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215499Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/11/2025	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215499s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215499Orig1s009ltr.pdf
09/20/2024	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215499s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215499Orig1s008ltr.pdf
12/13/2023	SUPPL-4	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215499Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215499Orig1s004ltr.pdf
02/27/2023	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215499s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215499Orig1s002ltr.pdf

Labels for NDA 215499

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/11/2025	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215499s009lbl.pdf
09/20/2024	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215499s008lbl.pdf
12/13/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215499Orig1s004lbl.pdf
12/13/2023	SUPPL-4	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215499Orig1s004lbl.pdf
02/27/2023	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215499s002lbl.pdf
12/20/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215499s000lbl.pdf

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