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 42.

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 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…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 230 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
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…`
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…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 294 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N209940-001	I-916	2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209940-001	D-189	2026-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209940-001	NPP	2027-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209940-001	ODE-423	2030-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209940-001	ODE-495	2031-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209940-001	ODE-497	2031-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209940-002	I-916	2026-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209940-002	D-189	2026-08-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209940-002	NPP	2027-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209940-002	ODE-423	2030-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209940-002	ODE-495	2031-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209940-002	ODE-497	2031-08-30	`caaa826d4ba7…`
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…`

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): 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