Home Applications 209940 Application 209940
Type NDA
Sponsor MERCK SHARP DOHME Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PREVYMIS LETERMOVIR SOLUTION;INTRAVENOUS 240MG/12ML (20MG/ML) Yes Yes 002 PREVYMIS LETERMOVIR SOLUTION;INTRAVENOUS 480MG/24ML (20MG/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N209940-001 PREVYMIS LETERMOVIR 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 N209940-002 PREVYMIS LETERMOVIR 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209940-001 RE46791 2029-01-18 Drug substance, Drug product 2020-04-29 N209940-001 10603384 2033-02-28 Drug product 2020-04-29 N209940-002 RE46791 2029-01-18 Drug substance, Drug product 2020-04-29 N209940-002 10603384 2033-02-28 Drug product 2020-04-29
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.
Product history page 1 of 3 · 86 observed 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 2026-09-14 22:38:34 2026-08 N209940-001 PREVYMIS 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209940-002 PREVYMIS 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209940-001 PREVYMIS 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209940-002 PREVYMIS 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209940-001 PREVYMIS 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209940-002 PREVYMIS 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209940-001 PREVYMIS 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209940-002 PREVYMIS 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209940-001 PREVYMIS 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209940-002 PREVYMIS 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209940-001 PREVYMIS 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209940-002 PREVYMIS 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209940-001 PREVYMIS 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209940-002 PREVYMIS 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209940-001 PREVYMIS 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209940-002 PREVYMIS 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209940-001 PREVYMIS 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209940-002 PREVYMIS 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209940-001 PREVYMIS 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209940-002 PREVYMIS 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209940-001 PREVYMIS 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209940-002 PREVYMIS 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209940-001 PREVYMIS 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209940-002 PREVYMIS 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209940-001 PREVYMIS 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209940-002 PREVYMIS 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209940-001 PREVYMIS 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209940-002 PREVYMIS 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209940-001 PREVYMIS 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209940-002 PREVYMIS 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209940-001 PREVYMIS 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N209940-002 PREVYMIS 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209940-001 PREVYMIS 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209940-002 PREVYMIS 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209940-001 PREVYMIS 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N209940-002 PREVYMIS 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209940-001 PREVYMIS 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N209940-002 PREVYMIS 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209940-001 PREVYMIS 240MG/12ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N209940-002 PREVYMIS 480MG/24ML (20MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2017-11-08 74a2ff9319b5…
Observed Orange Book patent history# Patent history page 1 of 6 · 234 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N209940-001 RE46791 2029-01-18 Drug substance, Drug product 2020-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209940-001 10603384 2033-02-28 Drug product 2020-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209940-002 RE46791 2029-01-18 Drug substance, Drug product 2020-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209940-002 10603384 2033-02-28 Drug product 2020-04-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209940-001 RE46791 2029-01-18 Drug substance, Drug product 2020-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209940-001 10603384 2033-02-28 Drug product 2020-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209940-002 RE46791 2029-01-18 Drug substance, Drug product 2020-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209940-002 10603384 2033-02-28 Drug product 2020-04-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209940-001 RE46791 2029-01-18 Drug substance, Drug product 2020-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209940-001 10603384 2033-02-28 Drug product 2020-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209940-002 RE46791 2029-01-18 Drug substance, Drug product 2020-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209940-002 10603384 2033-02-28 Drug product 2020-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209940-001 RE46791 2029-01-18 Drug substance, Drug product 2020-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209940-001 10603384 2033-02-28 Drug product 2020-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209940-002 RE46791 2029-01-18 Drug substance, Drug product 2020-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209940-002 10603384 2033-02-28 Drug product 2020-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209940-001 RE46791 2029-01-18 Drug substance, Drug product 2020-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209940-001 10603384 2033-02-28 Drug product 2020-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209940-002 RE46791 2029-01-18 Drug substance, Drug product 2020-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209940-002 10603384 2033-02-28 Drug product 2020-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209940-001 RE46791 2029-01-18 Drug substance, Drug product 2020-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209940-001 10603384 2033-02-28 Drug product 2020-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209940-002 RE46791 2029-01-18 Drug substance, Drug product 2020-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209940-002 10603384 2033-02-28 Drug product 2020-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209940-001 RE46791 2029-01-18 Drug substance, Drug product 2020-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209940-001 10603384 2033-02-28 Drug product 2020-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209940-002 RE46791 2029-01-18 Drug substance, Drug product 2020-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209940-002 10603384 2033-02-28 Drug product 2020-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209940-001 8513255 2024-05-22 Drug substance, Drug product 2017-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209940-001 RE46791 2029-01-18 Drug substance, Drug product 2020-04-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209940-001 10603384 2033-02-28 Drug product 2020-04-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209940-002 8513255 2024-05-22 Drug substance, Drug product 2017-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209940-002 RE46791 2029-01-18 Drug substance, Drug product 2020-04-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209940-002 10603384 2033-02-28 Drug product 2020-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209940-001 8513255 2024-05-22 Drug substance, Drug product 2017-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209940-001 RE46791 2029-01-18 Drug substance, Drug product 2020-04-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209940-001 10603384 2033-02-28 Drug product 2020-04-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209940-002 8513255 2024-05-22 Drug substance, Drug product 2017-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209940-002 RE46791 2029-01-18 Drug substance, Drug product 2020-04-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209940-002 10603384 2033-02-28 Drug product 2020-04-29 2680178bc6a6…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 8 · 306 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 0006-5003 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-5003 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-5003 PREVYMIS LETERMOVIR Merck Sharp & Dohme LLC NDA Current 0006-5003 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-5003 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-5003 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-5003 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-5003 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-5004 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-5004 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-5004 PREVYMIS LETERMOVIR Merck Sharp & Dohme LLC NDA Current 0006-5004 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-5004 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-5004 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-5004 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current 0006-5004 PREVYMIS LETERMOVIR Merck Sharp & Dohme Corp. NDA Current