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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212887
Company: VIIV HLTHCARE

Products on NDA 212887

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VOCABRIA	CABOTEGRAVIR SODIUM	EQ 30MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212887

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 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212887s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212887Orig1s000ltr.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
12/13/2023	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212887s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212887Orig1s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212887Orig1s008ltr.pdf
02/27/2023	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212887s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212887Orig1s007ltr.pdf
03/29/2022	SUPPL-6	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212887s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212887Orig1s005,s006ltr.pdf
03/29/2022	SUPPL-5	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212887s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212887Orig1s005,s006ltr.pdf
12/20/2021	SUPPL-4	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212887s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212887Orig1s004ltr.pdf
03/23/2022	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212887s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212887Orig1s003ltr.pdf
02/07/2022	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212887s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212887Orig1s002ltr.pdf
01/31/2022	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212887s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212887Orig1s001ltr.pdf

Labels for NDA 212887

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2023	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212887s008lbl.pdf
02/27/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212887s007lbl.pdf
03/29/2022	SUPPL-6	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212887s005s006lbl.pdf
03/29/2022	SUPPL-5	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212887s005s006lbl.pdf
03/23/2022	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212887s003lbl.pdf
02/07/2022	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212887s002lbl.pdf
01/31/2022	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212887s001lbl.pdf
12/20/2021	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212887s004lbl.pdf
01/21/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212887s000lbl.pdf

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