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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209939

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PREVYMIS (LETERMOVIR)
240MG
Marketing Status: Prescription
Active Ingredient: LETERMOVIR
Proprietary Name: PREVYMIS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 240MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209939
Product Number: 001
Approval Date: Nov 8, 2017
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
PREVYMIS (LETERMOVIR)
480MG
Marketing Status: Prescription
Active Ingredient: LETERMOVIR
Proprietary Name: PREVYMIS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 480MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209939
Product Number: 002
Approval Date: Nov 8, 2017
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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