Home Applications 209939 Application 209939
Type NDA
Sponsor MERCK SHARP DOHME Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PREVYMIS LETERMOVIR TABLET;ORAL 240MG Yes No 002 PREVYMIS LETERMOVIR TABLET;ORAL 480MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209939-001 PREVYMIS LETERMOVIR 240MG TABLET / ORAL RLD 2017-11-08 N209939-002 PREVYMIS LETERMOVIR 480MG TABLET / ORAL RLD, RS 2017-11-08
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209939-001 RE46791 2029-01-18 Drug substance, Drug product 2020-04-21 N209939-002 RE46791 2029-01-18 Drug substance, Drug product 2020-04-21
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 12 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N209939-001 PREVYMIS 240MG TABLET / ORAL RLD 2017-11-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N209939-002 PREVYMIS 480MG TABLET / ORAL RLD, RS 2017-11-08 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N209939-001 RE46791 2029-01-18 Drug substance, Drug product 2020-04-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N209939-002 RE46791 2029-01-18 Drug substance, Drug product 2020-04-21 a50c72e98297…
Observed Orange Book exclusivity history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0006-3075 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-3075 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-3075 PREVYMIS LETERMOVIR Merck Sharp & Dohme LLC NDA Current 0006-3075 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-3075 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-3075 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-3075 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-3075 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-3076 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-3076 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-3076 PREVYMIS LETERMOVIR Merck Sharp & Dohme LLC NDA Current 0006-3076 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-3076 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-3076 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-3076 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-3076 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current