New Drug Application (NDA): 215973
Company: GILEAD SCIENCES INC

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUNLENCA	LENACAPAVIR SODIUM	EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2022	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215973s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215973Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/215973,215974Orig1s000TOC.html

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/27/2026	SUPPL-24	Efficacy-Labeling Change With Clinical Data	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215973Orig1s024ltr.pdf
03/12/2026	SUPPL-19	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215973s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215973Orig1s019;215974Orig1s014ltr.pdf
11/13/2024	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
11/25/2024	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215973s006,215974s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215973Orig1s006,215974Orig1s008ltr.pdf
07/17/2024	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215973s005,215974s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215973Orig1s005,215974Orig1s007ltr.pdf

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
03/12/2026	SUPPL-19	Labeling-Patient Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215973s019lbl.pdf
03/12/2026	SUPPL-19	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215973s019lbl.pdf
11/25/2024	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215973s006,215974s008lbl.pdf
07/17/2024	SUPPL-5	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215973s005,215974s007lbl.pdf
12/22/2022	ORIG-1	Approval	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215973s000lbl.pdf