Application 214787

Type: NDA
Sponsor: GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VEKLURY	REMDESIVIR	INJECTABLE;INJECTION	5MG/ML	Yes	No
002	VEKLURY	REMDESIVIR	INJECTABLE;INJECTION	100MG/VIAL	Yes	No

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
N214787-001	VEKLURY	REMDESIVIR	100MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2020-10-22
N214787-002	VEKLURY	REMDESIVIR	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD	2020-10-22

Orange Book patents#

Current patent rows page 1 of 1 · 71 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214787-001	8318682	2029-04-22		Drug substance, Drug product	2020-11-12
N214787-001	RE46762	2029-04-22		Drug substance, Drug product	2020-11-12
N214787-001	8008264	2029-09-06		Drug substance, Drug product	2020-11-12
N214787-001	8318682*PED	2029-10-22		Pediatric extension
N214787-001	RE46762*PED	2029-10-22		Pediatric extension
N214787-001	8008264*PED	2030-03-06		Pediatric extension
N214787-001	10065958	2031-09-16		Drug substance	2020-11-12
N214787-001	11492353	2031-12-08		Drug substance	2022-12-06
N214787-001	10065958*PED	2032-03-16		Pediatric extension
N214787-001	11492353*PED	2032-06-08		Pediatric extension
N214787-001	9724360	2035-10-29		Drug substance, Drug product	2020-11-12
N214787-001	9949994	2035-10-29		Drug substance	2020-11-12
N214787-001	9724360*PED	2036-04-29		Pediatric extension
N214787-001	9949994*PED	2036-04-29		Pediatric extension
N214787-001	10695361	2036-09-16	U-3831		2020-11-12
N214787-001	10695361	2036-09-16	U-3832		2020-11-12
N214787-001	11007208	2036-09-16	U-3831		2021-06-15
N214787-001	11007208	2036-09-16	U-3832		2021-06-15
N214787-001	11382926	2036-09-16	U-3831		2022-08-02
N214787-001	11382926	2036-09-16	U-3832		2022-08-02
N214787-001	10695361*PED	2037-03-16		Pediatric extension
N214787-001	11007208*PED	2037-03-16		Pediatric extension
N214787-001	11382926*PED	2037-03-16		Pediatric extension
N214787-001	10675296	2038-07-10		Drug product	2020-11-12
N214787-001	11266681	2038-07-10	U-3831		2022-04-04
N214787-001	11266681	2038-07-10	U-3832		2022-04-04
N214787-001	11975017	2038-07-10		Drug product	2024-06-05
N214787-001	10675296*PED	2039-01-10		Pediatric extension
N214787-001	11266681*PED	2039-01-10		Pediatric extension
N214787-001	11975017*PED	2039-01-10		Pediatric extension
N214787-001	11491169	2041-05-28	U-3835		2022-12-06
N214787-001	11491169	2041-05-28	U-3836		2022-12-06
N214787-001	11903953	2041-05-28	U-3835		2024-03-19
N214787-001	11903953	2041-05-28	U-3836		2024-03-19
N214787-001	11975012	2041-05-28	U-3835		2024-06-05
N214787-001	11975012	2041-05-28	U-3836		2024-06-05
N214787-001	11491169*PED	2041-11-28		Pediatric extension
N214787-001	11903953*PED	2041-11-28		Pediatric extension
N214787-001	11975012*PED	2041-11-28		Pediatric extension
N214787-002	8318682	2029-04-22		Drug substance, Drug product	2020-11-12
N214787-002	RE46762	2029-04-22		Drug substance, Drug product	2020-11-12
N214787-002	8008264	2029-09-06		Drug substance, Drug product	2020-11-12
N214787-002	8318682*PED	2029-10-22		Pediatric extension
N214787-002	RE46762*PED	2029-10-22		Pediatric extension
N214787-002	8008264*PED	2030-03-06		Pediatric extension
N214787-002	10065958	2031-09-16		Drug substance	2020-11-12
N214787-002	11492353	2031-12-08		Drug substance	2022-12-06
N214787-002	10065958*PED	2032-03-16		Pediatric extension
N214787-002	11492353*PED	2032-06-08		Pediatric extension
N214787-002	9724360	2035-10-29		Drug substance, Drug product	2020-11-12
N214787-002	9949994	2035-10-29		Drug substance	2020-11-12
N214787-002	9724360*PED	2036-04-29		Pediatric extension
N214787-002	9949994*PED	2036-04-29		Pediatric extension
N214787-002	10695361	2036-09-16	U-3829		2020-11-12
N214787-002	10695361	2036-09-16	U-3830		2020-11-12
N214787-002	11007208	2036-09-16	U-3829		2021-06-15
N214787-002	11007208	2036-09-16	U-3830		2021-06-15
N214787-002	11382926	2036-09-16	U-3829		2022-08-02
N214787-002	11382926	2036-09-16	U-3830		2022-08-02
N214787-002	10695361*PED	2037-03-16		Pediatric extension
N214787-002	11007208*PED	2037-03-16		Pediatric extension
N214787-002	11382926*PED	2037-03-16		Pediatric extension
N214787-002	11491169	2041-05-28	U-3833		2022-12-06
N214787-002	11491169	2041-05-28	U-3834		2022-12-06
N214787-002	11903953	2041-05-28	U-3833		2024-03-19
N214787-002	11903953	2041-05-28	U-3834		2024-03-19
N214787-002	11975012	2041-05-28	U-3833		2024-06-05
N214787-002	11975012	2041-05-28	U-3834		2024-06-05
N214787-002	11491169*PED	2041-11-28		Pediatric extension
N214787-002	11903953*PED	2041-11-28		Pediatric extension
N214787-002	11975012*PED	2041-11-28		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214787-001	NCE	2025-10-22
N214787-001	PED	2026-04-22
N214787-001	M-301	2026-07-13
N214787-001	PED	2027-01-13
N214787-002	NCE	2025-10-22
N214787-002	PED	2026-04-22
N214787-002	M-301	2026-07-13
N214787-002	PED	2027-01-13

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 2 · 72 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	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2020-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N214787-001	VEKLURY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-10-22	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N214787-002	VEKLURY	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-10-22	`87673890dc5c…`

Observed Orange Book patent history#

Patent history page 1 of 47 · 1,872 observed states.

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	N214787-001	8318682	2029-04-22		Drug substance, Drug product	2020-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	RE46762	2029-04-22		Drug substance, Drug product	2020-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	8008264	2029-09-06		Drug substance, Drug product	2020-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	8318682*PED	2029-10-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	RE46762*PED	2029-10-22		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	8008264*PED	2030-03-06		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	10065958	2031-09-16		Drug substance	2020-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11492353	2031-12-08		Drug substance	2022-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	10065958*PED	2032-03-16		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11492353*PED	2032-06-08		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	9724360	2035-10-29		Drug substance, Drug product	2020-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	9949994	2035-10-29		Drug substance	2020-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	9724360*PED	2036-04-29		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	9949994*PED	2036-04-29		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	10695361	2036-09-16	U-3831		2020-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	10695361	2036-09-16	U-3832		2020-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11007208	2036-09-16	U-3831		2021-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11007208	2036-09-16	U-3832		2021-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11382926	2036-09-16	U-3831		2022-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11382926	2036-09-16	U-3832		2022-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	10695361*PED	2037-03-16		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11007208*PED	2037-03-16		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11382926*PED	2037-03-16		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	10675296	2038-07-10		Drug product	2020-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11266681	2038-07-10	U-3832		2022-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11266681	2038-07-10	U-3831		2022-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11975017	2038-07-10		Drug product	2024-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	10675296*PED	2039-01-10		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11266681*PED	2039-01-10		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11975017*PED	2039-01-10		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11491169	2041-05-28	U-3836		2022-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11491169	2041-05-28	U-3835		2022-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11903953	2041-05-28	U-3835		2024-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11903953	2041-05-28	U-3836		2024-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11975012	2041-05-28	U-3835		2024-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11975012	2041-05-28	U-3836		2024-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11491169*PED	2041-11-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11903953*PED	2041-11-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	11975012*PED	2041-11-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-002	8318682	2029-04-22		Drug substance, Drug product	2020-11-12	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 9 · 352 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	N214787-001	NCE	2025-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	PED	2026-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	M-301	2026-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-001	PED	2027-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-002	NCE	2025-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-002	PED	2026-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-002	M-301	2026-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214787-002	PED	2027-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-001	D-183	2025-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-001	NPP	2025-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-001	PED	2025-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-001	NCE	2025-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-001	PED	2025-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-001	PED	2026-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-001	M-301	2026-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-001	PED	2027-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-002	D-183	2025-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-002	NPP	2025-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-002	PED	2025-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-002	NCE	2025-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-002	PED	2025-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-002	PED	2026-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-002	M-301	2026-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214787-002	PED	2027-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214787-001	D-183	2025-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-001	NPP	2025-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-001	PED	2025-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-001	NCE	2025-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-001	PED	2025-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-001	PED	2026-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-001	M-301	2026-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-001	PED	2027-01-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-002	D-183	2025-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-002	NPP	2025-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-002	PED	2025-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-002	NCE	2025-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-002	PED	2025-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-002	PED	2026-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-002	M-301	2026-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214787-002	PED	2027-01-13	`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
Veklury	REMDESIVIR	Gilead Sciences, Inc.	c0978fa8-53ff-4ca2-82a7-567fd3e958ca	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214787 application number: NDA214787 ndc (product): 61958-2901 ndc (product): 61958-2902

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61958-2901	Veklury	remdesivir	Gilead Sciences, Inc.	NDA	Current
61958-2901	Veklury	remdesivir	Gilead Sciences, Inc.	NDA	Current
61958-2901	Veklury	remdesivir	Gilead Sciences, Inc.	NDA	Current
61958-2901	Veklury	remdesivir	Gilead Sciences, Inc.	NDA	Current
61958-2901	Veklury	remdesivir	Gilead Sciences, Inc.	NDA	Current
61958-2901	Veklury	remdesivir	Gilead Sciences, Inc.	NDA	Current
61958-2901	Veklury	remdesivir	Gilead Sciences, Inc.	NDA	Current
61958-2901	Veklury	remdesivir	Gilead Sciences, Inc.	NDA	Current
61958-2901	Veklury	remdesivir	Gilead Sciences, Inc.	NDA	Current
61958-2901	Veklury	remdesivir	Gilead Sciences, Inc.	NDA	Current
61958-2901	Veklury	remdesivir	Gilead Sciences, Inc.	NDA	Current
61958-2902	Veklury	remdesivir	Gilead Sciences, Inc.	NDA	Current
61958-2902	Veklury	remdesivir	Gilead Sciences, Inc.	NDA	Current
61958-2902	Veklury	remdesivir	Gilead Sciences, Inc.	NDA	Current
61958-2902	Veklury	remdesivir	Gilead Sciences, Inc.	NDA	Current
61958-2902	Veklury	remdesivir	Gilead Sciences, Inc.	NDA	Current
61958-2902	Veklury	remdesivir	Gilead Sciences, Inc.	NDA	Current
61958-2902	Veklury	remdesivir	Gilead Sciences, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83718	SUPPL	2025-10-10
83690	SUPPL	2025-10-08
83199	SUPPL	2025-08-26
83182	SUPPL	2025-08-25
80842	SUPPL	2025-01-13
80840	SUPPL	2025-01-13
80684	SUPPL	2024-12-23
80662	SUPPL	2024-12-20
78931	SUPPL	2024-06-28
78926	SUPPL	2024-06-28
77682	SUPPL	2024-03-01
77658	SUPPL	2024-02-29
77648	SUPPL	2024-02-28
75274	SUPPL	2023-08-24
75266	SUPPL	2023-08-23
75123	SUPPL	2023-08-18
75116	SUPPL	2023-08-18
74758	SUPPL	2023-07-14
74756	SUPPL	2023-07-13
74488	SUPPL	2023-06-13
74483	SUPPL	2023-06-13
74469	SUPPL	2023-06-09
74463	SUPPL	2023-06-08
74142	SUPPL	2023-05-02
74122	SUPPL	2023-05-01
73908	SUPPL	2023-03-30
73905	SUPPL	2023-03-30
72908	SUPPL	2022-12-15
72895	SUPPL	2022-12-15
72482	SUPPL	2022-10-27
72463	SUPPL	2022-10-25
72216	SUPPL	2022-10-03
72189	SUPPL	2022-09-30
71451	SUPPL	2022-06-27
71449	SUPPL	2022-06-24
71444	SUPPL	2022-06-24
70870	SUPPL	2022-05-02
70818	SUPPL	2022-04-27
70813	SUPPL	2022-04-26
70606	SUPPL	2022-03-25
70604	SUPPL	2022-03-25
70346	SUPPL	2022-03-02
69975	SUPPL	2022-01-26
69953	SUPPL	2022-01-24
69951	SUPPL	2022-01-21
69935	SUPPL	2022-01-20
69929	SUPPL	2022-01-20
66353	SUPPL	2021-02-24
66340	SUPPL	2021-02-23
65346	ORIG	2020-11-25
64980	ORIG	2020-10-22
64979	ORIG	2020-10-22
64978	ORIG	2020-10-22