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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210806
Company: MSD MERCK CO

Products on NDA 210806

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PIFELTRO	DORAVIRINE	100MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210806

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/30/2018	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210806s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210806Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210806Orig1s000,210807Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/07/2024	SUPPL-11	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210806s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210806Orig1s011ltr.pdf
01/27/2022	SUPPL-7	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210806s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210806Orig1s007ltr.pdf
10/10/2019	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210806s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210806Orig1s003ltr.pdf
09/19/2019	SUPPL-2	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210806s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210806Orig1s002ltr.pdf

Labels for NDA 210806

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/07/2024	SUPPL-11	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210806s011lbl.pdf
11/07/2024	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210806s011lbl.pdf
01/27/2022	SUPPL-7	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210806s007lbl.pdf
10/10/2019	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210806s003lbl.pdf
09/19/2019	SUPPL-2	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210806s002lbl.pdf
08/30/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210806s000lbl.pdf

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