Home Applications 219104 Application 219104
Type NDA
Sponsor MSD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PREVYMIS LETERMOVIR PELLETS;ORAL 20MG/PACKET Yes No 002 PREVYMIS LETERMOVIR PELLETS;ORAL 120MG/PACKET 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 N219104-001 PREVYMIS LETERMOVIR 20MG/PACKET PELLETS / ORAL RLD 2024-08-30 N219104-002 PREVYMIS LETERMOVIR 120MG/PACKET PELLETS / ORAL RLD, RS 2024-08-30
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 N219104-001 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 N219104-002 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 8 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 2026-02-19 14:30 UTC 2026-02 N219104-001 PREVYMIS 20MG/PACKET PELLETS / ORAL RLD 2024-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219104-002 PREVYMIS 120MG/PACKET PELLETS / ORAL RLD, RS 2024-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219104-001 PREVYMIS 20MG/PACKET PELLETS / ORAL RLD 2024-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219104-002 PREVYMIS 120MG/PACKET PELLETS / ORAL RLD, RS 2024-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219104-001 PREVYMIS 20MG/PACKET PELLETS / ORAL RLD 2024-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219104-002 PREVYMIS 120MG/PACKET PELLETS / ORAL RLD, RS 2024-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219104-001 PREVYMIS 20MG/PACKET PELLETS / ORAL RLD 2024-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219104-002 PREVYMIS 120MG/PACKET PELLETS / ORAL RLD, RS 2024-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N219104-001 PREVYMIS 20MG/PACKET PELLETS / ORAL RLD 2024-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N219104-002 PREVYMIS 120MG/PACKET PELLETS / ORAL RLD, RS 2024-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N219104-001 PREVYMIS 20MG/PACKET PELLETS / ORAL RLD 2024-08-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N219104-002 PREVYMIS 120MG/PACKET PELLETS / ORAL RLD, RS 2024-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N219104-001 PREVYMIS 20MG/PACKET PELLETS / ORAL RLD 2024-08-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N219104-002 PREVYMIS 120MG/PACKET PELLETS / ORAL RLD, RS 2024-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N219104-001 PREVYMIS 20MG/PACKET PELLETS / ORAL RLD 2024-08-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N219104-002 PREVYMIS 120MG/PACKET PELLETS / ORAL RLD, RS 2024-08-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N219104-001 PREVYMIS 20MG/PACKET PELLETS / ORAL RLD 2024-08-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N219104-002 PREVYMIS 120MG/PACKET PELLETS / ORAL RLD, RS 2024-08-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N219104-001 PREVYMIS 20MG/PACKET PELLETS / ORAL RLD 2024-08-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N219104-002 PREVYMIS 120MG/PACKET PELLETS / ORAL RLD, RS 2024-08-30 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219104-001 PREVYMIS 20MG/PACKET PELLETS / ORAL RLD 2024-08-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219104-002 PREVYMIS 120MG/PACKET PELLETS / ORAL RLD, RS 2024-08-30 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 2026-02-19 14:30 UTC 2026-02 N219104-001 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219104-002 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219104-001 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219104-002 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219104-001 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219104-002 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219104-001 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219104-002 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N219104-001 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N219104-002 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N219104-001 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N219104-002 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N219104-001 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N219104-002 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N219104-001 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N219104-002 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N219104-001 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N219104-002 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219104-001 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219104-002 RE46791 2029-01-18 Drug substance, Drug product 2024-09-25 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 84 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 PREVYMIS LETERMOVIR Merck Sharp & Dohme LLC 1b49df80-be4f-47e0-a0b7-123f3e69395b 2026-01-14 Warnings, Adverse reactions Exact identifier application applno (NDA): 219104 application number: NDA219104
Documents# Document, Submission type, Date table Document Submission type Date 82881 ORIG 2025-07-16 81088 SUPPL 2025-02-06 80991 SUPPL 2025-02-05 79538 ORIG 2024-09-03 79517 ORIG 2024-09-02