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 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
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	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.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N209940-001	I-916	2026-06-05
N209940-001	D-189	2026-08-02
N209940-001	NPP	2027-08-30
N209940-001	ODE-423	2030-06-05
N209940-001	ODE-495	2031-08-30
N209940-001	ODE-497	2031-08-30
N209940-002	I-916	2026-06-05
N209940-002	D-189	2026-08-02
N209940-002	NPP	2027-08-30
N209940-002	ODE-423	2030-06-05
N209940-002	ODE-495	2031-08-30
N209940-002	ODE-497	2031-08-30

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	N209940-001	PREVYMIS	240MG/12ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-11-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209940-002	PREVYMIS	480MG/24ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-11-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209940-001	PREVYMIS	240MG/12ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-11-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209940-002	PREVYMIS	480MG/24ML (20MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-11-08	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 226 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
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…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209940-001	8513255	2024-05-22	Drug substance, Drug product	2017-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209940-001	RE46791	2029-01-18	Drug substance, Drug product	2020-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209940-001	10603384	2033-02-28	Drug product	2020-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209940-002	8513255	2024-05-22	Drug substance, Drug product	2017-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209940-002	RE46791	2029-01-18	Drug substance, Drug product	2020-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209940-002	10603384	2033-02-28	Drug product	2020-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209940-001	8513255	2024-05-22	Drug substance, Drug product	2017-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209940-001	RE46791	2029-01-18	Drug substance, Drug product	2020-04-29	`d8e5a09893c0…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 282 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209940-001	I-916	2026-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209940-001	D-189	2026-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209940-001	NPP	2027-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209940-001	ODE-423	2030-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209940-001	ODE-495	2031-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209940-001	ODE-497	2031-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209940-002	I-916	2026-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209940-002	D-189	2026-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209940-002	NPP	2027-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209940-002	ODE-423	2030-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209940-002	ODE-495	2031-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209940-002	ODE-497	2031-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209940-001	I-916	2026-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209940-001	D-189	2026-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209940-001	NPP	2027-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209940-001	ODE-423	2030-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209940-001	ODE-495	2031-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209940-001	ODE-497	2031-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209940-002	I-916	2026-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209940-002	D-189	2026-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209940-002	NPP	2027-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209940-002	ODE-423	2030-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209940-002	ODE-495	2031-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209940-002	ODE-497	2031-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209940-001	I-916	2026-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209940-001	D-189	2026-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209940-001	NPP	2027-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209940-001	ODE-423	2030-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209940-001	ODE-495	2031-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209940-001	ODE-497	2031-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209940-002	I-916	2026-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209940-002	D-189	2026-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209940-002	NPP	2027-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209940-002	ODE-423	2030-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209940-002	ODE-495	2031-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209940-002	ODE-497	2031-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209940-001	I-916	2026-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209940-001	D-189	2026-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209940-001	NPP	2027-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209940-001	ODE-423	2030-06-05	`fd3edfee7708…`

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
PREVYMIS	LETERMOVIR	Merck Sharp & Dohme LLC	1b49df80-be4f-47e0-a0b7-123f3e69395b	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209940 application number: NDA209940 ndc (product): 0006-5003 ndc (product): 0006-5004

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81087	SUPPL	2025-02-06
80990	SUPPL	2025-02-05
79521	SUPPL	2024-10-15
79520	SUPPL	2024-10-15
79535	SUPPL	2024-09-03
79534	SUPPL	2024-09-03
74991	SUPPL	2023-08-04
74978	SUPPL	2023-08-03
74453	SUPPL	2023-06-06
74436	SUPPL	2023-06-06
62303	SUPPL	2020-03-24
62280	SUPPL	2020-03-24
61447	SUPPL	2019-12-26
61418	SUPPL	2019-12-23
59896	SUPPL	2019-09-03
59884	SUPPL	2019-08-30
57925	SUPPL	2019-03-07
57920	SUPPL	2019-03-07
50756	ORIG	2017-12-18
50347	ORIG	2017-11-08
50346	ORIG	2017-11-08