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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209939
Company: MERCK SHARP DOHME

Products on NDA 209939

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREVYMIS	LETERMOVIR	240MG	TABLET;ORAL	Prescription	None	Yes	No
PREVYMIS	LETERMOVIR	480MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209939

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/08/2017	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209939Orig1s000,209940Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209939Orig1s000,209940Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209939Orig1s000,209940Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2023	SUPPL-12	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209939Orig1s012;209940Orig1s011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209939Orig1s012;209940Orig1s011ltr.pdf
08/02/2023	SUPPL-11	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209939s011,209940s010lbl.pdf
01/20/2023	SUPPL-10	Manufacturing (CMC)-Facility	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209939Orig1s011,209940Orig1s010ltr.pdf
03/23/2020	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209939s008,209940s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209939Orig1s008, 209940Orig1s006ltr.pdf
12/20/2019	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209939s006,209940s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209939Orig1s006; 209940Orig1s004ltr.pdf
08/29/2019	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209939s005,209940s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209939Orig1s005, 209940Orig1s003ltr.pdf
03/05/2019	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209939s003,209940s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209939Orig1s003,209940Orig1s001ltr.pdf

Labels for NDA 209939

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/02/2023	SUPPL-11	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209939s011,209940s010lbl.pdf
06/05/2023	SUPPL-12	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209939Orig1s012;209940Orig1s011ltr.pdf
03/23/2020	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209939s008,209940s006lbl.pdf
12/20/2019	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209939s006,209940s004lbl.pdf
08/29/2019	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209939s005,209940s003lbl.pdf
08/29/2019	SUPPL-5	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209939s005,209940s003lbl.pdf
03/05/2019	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209939s003,209940s001lbl.pdf
11/08/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209939Orig1s000,209940Orig1s000lbl.pdf

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