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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212888
Company: VIIV HLTHCARE

Products on NDA 212888

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CABENUVA KIT	CABOTEGRAVIR; RILPIVIRINE	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription	None	Yes	Yes
CABENUVA KIT	CABOTEGRAVIR; RILPIVIRINE	600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212888

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/21/2021	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212888s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212888Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/212887Orig1s000,212888Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/20/2024	SUPPL-15	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212888s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212888Orig1s015ltr.pdf
12/13/2023	SUPPL-11	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212888s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212888Orig1s011ltr.pdf
02/27/2023	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212888s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212888Orig1s008ltr.pdf
03/29/2022	SUPPL-6	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212888s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212888Orig1s005,s006ltr.pdf
03/29/2022	SUPPL-5	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212888s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212888Orig1s005,s006ltr.pdf
03/23/2022	SUPPL-3	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212888s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212888Orig1s003ltr.pdf
02/07/2022	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212888s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212888Orig1s002ltr.pdf
01/31/2022	SUPPL-1	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212888s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212888Orig1s001ltr.pdf

Labels for NDA 212888

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/20/2024	SUPPL-15	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212888s015lbl.pdf
12/13/2023	SUPPL-11	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212888s011lbl.pdf
12/13/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212888s011lbl.pdf
02/27/2023	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212888s008lbl.pdf
03/29/2022	SUPPL-6	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212888s005s006lbl.pdf
03/29/2022	SUPPL-5	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212888s005s006lbl.pdf
03/23/2022	SUPPL-3	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212888s003lbl.pdf
02/07/2022	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212888s002lbl.pdf
01/31/2022	SUPPL-1	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212888s001lbl.pdf
01/21/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212888s000lbl.pdf

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