Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 219104
Company: MSD

Products on NDA 219104

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREVYMIS	LETERMOVIR	20MG/PACKET	PELLETS;ORAL	Prescription	None	Yes	No
PREVYMIS	LETERMOVIR	120MG/PACKET	PELLETS;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 219104

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/30/2024	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219104s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/219104Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/219104Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/30/2025	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209939s015,209940s015,219104s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209939Orig1s015;209940Orig1s015;219104Orig1s001ltr.pdf

Labels for NDA 219104

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/30/2025	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209939s015,209940s015,219104s001lbl.pdf
08/30/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219104s000lbl.pdf