Home Applications 208261 Application 208261
Type NDA
Sponsor MERCK SHARP DOHME Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZEPATIER ELBASVIR; GRAZOPREVIR TABLET;ORAL 50MG;100MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208261-001 ZEPATIER ELBASVIR; GRAZOPREVIR 50MG;100MG TABLET / ORAL RLD 2016-01-28
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 N208261-001 7973040 2029-07-24 U-1813 Drug substance, Drug product 2016-02-25 N208261-001 8871759 2031-05-04 U-1813 Drug substance, Drug product 2016-02-25
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 N208261-001 ZEPATIER 50MG;100MG TABLET / ORAL RLD 2016-01-28 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 N208261-001 7973040 2029-07-24 U-1813 Drug substance, Drug product 2016-02-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N208261-001 8871759 2031-05-04 U-1813 Drug substance, Drug product 2016-02-25 a50c72e98297…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZEPATIER ELBASVIR AND GRAZOPREVIR Merck Sharp & Dohme LLC 164dc02a-9180-426a-b8b5-04ab39d2bbd4 2026-03-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 208261 application number: NDA208261 ndc (product): 0006-3074
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0006-3074 ZEPATIER elbasvir and grazoprevir Merck Sharp & Dohme Corp. NDA Current 0006-3074 ZEPATIER elbasvir and grazoprevir Merck Sharp & Dohme Corp. NDA Current 0006-3074 ZEPATIER elbasvir and grazoprevir Merck Sharp & Dohme Corp. NDA Current 0006-3074 ZEPATIER elbasvir and grazoprevir Merck Sharp & Dohme Corp. NDA Current 0006-3074 ZEPATIER elbasvir and grazoprevir Merck Sharp & Dohme LLC NDA Current 0006-3074 ZEPATIER elbasvir and grazoprevir Merck Sharp & Dohme Corp. NDA Current 0006-3074 ZEPATIER elbasvir and grazoprevir Merck Sharp & Dohme Corp. NDA Current