Application 208341

Type: NDA
Sponsor: GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPCLUSA	SOFOSBUVIR; VELPATASVIR	TABLET;ORAL	400MG;100MG	Yes	Yes
002	EPCLUSA	SOFOSBUVIR; VELPATASVIR	TABLET;ORAL	200MG;50MG	Yes	No

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
N208341-001	EPCLUSA	SOFOSBUVIR; VELPATASVIR	400MG;100MG	TABLET / ORAL		RLD, RS	2016-06-28
N208341-002	EPCLUSA	SOFOSBUVIR; VELPATASVIR	200MG;50MG	TABLET / ORAL		RLD	2020-03-19

Orange Book patents#

Current patent rows page 1 of 1 · 60 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208341-001	8334270	2028-03-21	U-1470	Drug substance, Drug product	2016-07-15
N208341-001	8580765	2028-03-21	U-1470	Drug substance, Drug product	2016-07-15
N208341-001	8735372	2028-03-21	U-1470		2016-07-15
N208341-001	9085573	2028-03-21	U-1470	Drug substance, Drug product	2016-07-15
N208341-001	8334270*PED	2028-09-21		Pediatric extension
N208341-001	8580765*PED	2028-09-21		Pediatric extension
N208341-001	8735372*PED	2028-09-21		Pediatric extension
N208341-001	9085573*PED	2028-09-21		Pediatric extension
N208341-001	7964580	2029-03-26	U-1470	Drug substance, Drug product	2016-07-15
N208341-001	8633309	2029-03-26	U-1470	Drug substance, Drug product	2016-07-15
N208341-001	8889159	2029-03-26	U-1470	Drug product	2016-07-15
N208341-001	7964580*PED	2029-09-26		Pediatric extension
N208341-001	8633309*PED	2029-09-26		Pediatric extension
N208341-001	8889159*PED	2029-09-26		Pediatric extension
N208341-001	9284342	2030-09-13	U-1470	Drug substance, Drug product	2016-07-15
N208341-001	8618076	2030-12-11	U-1470	Drug substance, Drug product	2016-07-15
N208341-001	9284342*PED	2031-03-13		Pediatric extension
N208341-001	8618076*PED	2031-06-11		Pediatric extension
N208341-001	8575135	2032-11-16	U-1470	Drug substance, Drug product	2016-07-15
N208341-001	8921341	2032-11-16	U-1470	Drug substance, Drug product	2016-07-15
N208341-001	8940718	2032-11-16	U-1470	Drug substance, Drug product	2016-07-15
N208341-001	8575135*PED	2033-05-16		Pediatric extension
N208341-001	8921341*PED	2033-05-16		Pediatric extension
N208341-001	8940718*PED	2033-05-16		Pediatric extension
N208341-001	10086011	2034-01-30	U-1470		2018-10-23
N208341-001	11116783	2034-01-30	U-1470	Drug product	2021-10-01
N208341-001	9757406	2034-01-30		Drug product	2017-09-26
N208341-001	10086011*PED	2034-07-30		Pediatric extension
N208341-001	11116783*PED	2034-07-30		Pediatric extension
N208341-001	9757406*PED	2034-07-30		Pediatric extension
N208341-002	8334270	2028-03-21	U-1470	Drug substance, Drug product	2020-04-16
N208341-002	8580765	2028-03-21	U-1470	Drug substance, Drug product	2020-04-16
N208341-002	8735372	2028-03-21	U-1470		2020-04-16
N208341-002	9085573	2028-03-21	U-1470	Drug substance, Drug product	2020-04-16
N208341-002	8334270*PED	2028-09-21		Pediatric extension
N208341-002	8580765*PED	2028-09-21		Pediatric extension
N208341-002	8735372*PED	2028-09-21		Pediatric extension
N208341-002	9085573*PED	2028-09-21		Pediatric extension
N208341-002	7964580	2029-03-26	U-1470	Drug substance, Drug product	2020-04-16
N208341-002	8633309	2029-03-26	U-1470	Drug substance, Drug product	2020-04-16
N208341-002	8889159	2029-03-26	U-1470	Drug product	2020-04-16
N208341-002	7964580*PED	2029-09-26		Pediatric extension
N208341-002	8633309*PED	2029-09-26		Pediatric extension
N208341-002	8889159*PED	2029-09-26		Pediatric extension
N208341-002	9284342	2030-09-13	U-1470	Drug substance, Drug product	2020-04-16
N208341-002	8618076	2030-12-11	U-1470	Drug substance, Drug product	2020-04-16
N208341-002	9284342*PED	2031-03-13		Pediatric extension
N208341-002	8618076*PED	2031-06-11		Pediatric extension
N208341-002	8575135	2032-11-16	U-1470	Drug substance, Drug product	2020-04-16
N208341-002	8921341	2032-11-16	U-1470	Drug substance, Drug product	2020-04-16
N208341-002	8940718	2032-11-16	U-1470	Drug substance, Drug product	2020-04-16
N208341-002	8575135*PED	2033-05-16		Pediatric extension
N208341-002	8921341*PED	2033-05-16		Pediatric extension
N208341-002	8940718*PED	2033-05-16		Pediatric extension
N208341-002	10086011	2034-01-30	U-1470		2020-04-16
N208341-002	11116783	2034-01-30	U-1470	Drug product	2021-10-01
N208341-002	9757406	2034-01-30		Drug product	2020-04-16
N208341-002	10086011*PED	2034-07-30		Pediatric extension
N208341-002	11116783*PED	2034-07-30		Pediatric extension
N208341-002	9757406*PED	2034-07-30		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208341-001	ODE-293	2027-03-19
N208341-001	PED	2027-09-19
N208341-002	ODE-293	2027-03-19
N208341-002	PED	2027-09-19

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
2026-09-14 22:38:34	2026-08	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-002	EPCLUSA	200MG;50MG	TABLET / ORAL	RLD	2020-03-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208341-002	EPCLUSA	200MG;50MG	TABLET / ORAL	RLD	2020-03-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208341-002	EPCLUSA	200MG;50MG	TABLET / ORAL	RLD	2020-03-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208341-002	EPCLUSA	200MG;50MG	TABLET / ORAL	RLD	2020-03-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208341-002	EPCLUSA	200MG;50MG	TABLET / ORAL	RLD	2020-03-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208341-002	EPCLUSA	200MG;50MG	TABLET / ORAL	RLD	2020-03-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208341-002	EPCLUSA	200MG;50MG	TABLET / ORAL	RLD	2020-03-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208341-002	EPCLUSA	200MG;50MG	TABLET / ORAL	RLD	2020-03-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208341-002	EPCLUSA	200MG;50MG	TABLET / ORAL	RLD	2020-03-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208341-002	EPCLUSA	200MG;50MG	TABLET / ORAL	RLD	2020-03-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208341-002	EPCLUSA	200MG;50MG	TABLET / ORAL	RLD	2020-03-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208341-002	EPCLUSA	200MG;50MG	TABLET / ORAL	RLD	2020-03-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208341-002	EPCLUSA	200MG;50MG	TABLET / ORAL	RLD	2020-03-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208341-002	EPCLUSA	200MG;50MG	TABLET / ORAL	RLD	2020-03-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208341-002	EPCLUSA	200MG;50MG	TABLET / ORAL	RLD	2020-03-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208341-002	EPCLUSA	200MG;50MG	TABLET / ORAL	RLD	2020-03-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208341-002	EPCLUSA	200MG;50MG	TABLET / ORAL	RLD	2020-03-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208341-002	EPCLUSA	200MG;50MG	TABLET / ORAL	RLD	2020-03-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208341-002	EPCLUSA	200MG;50MG	TABLET / ORAL	RLD	2020-03-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208341-001	EPCLUSA	400MG;100MG	TABLET / ORAL	RLD, RS	2016-06-28	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 59 · 2,324 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	N208341-001	8334270	2028-03-21	U-1470	Drug substance, Drug product	2016-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	8580765	2028-03-21	U-1470	Drug substance, Drug product	2016-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	8735372	2028-03-21	U-1470		2016-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	9085573	2028-03-21	U-1470	Drug substance, Drug product	2016-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	8334270*PED	2028-09-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	8580765*PED	2028-09-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	8735372*PED	2028-09-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	9085573*PED	2028-09-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	7964580	2029-03-26	U-1470	Drug substance, Drug product	2016-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	8633309	2029-03-26	U-1470	Drug substance, Drug product	2016-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	8889159	2029-03-26	U-1470	Drug product	2016-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	7964580*PED	2029-09-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	8633309*PED	2029-09-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	8889159*PED	2029-09-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	9284342	2030-09-13	U-1470	Drug substance, Drug product	2016-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	8618076	2030-12-11	U-1470	Drug substance, Drug product	2016-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	9284342*PED	2031-03-13		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	8618076*PED	2031-06-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	8575135	2032-11-16	U-1470	Drug substance, Drug product	2016-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	8921341	2032-11-16	U-1470	Drug substance, Drug product	2016-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	8940718	2032-11-16	U-1470	Drug substance, Drug product	2016-07-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	8575135*PED	2033-05-16		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	8921341*PED	2033-05-16		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	8940718*PED	2033-05-16		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	10086011	2034-01-30	U-1470		2018-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	11116783	2034-01-30	U-1470	Drug product	2021-10-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	9757406	2034-01-30		Drug product	2017-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	10086011*PED	2034-07-30		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	11116783*PED	2034-07-30		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	9757406*PED	2034-07-30		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-002	8334270	2028-03-21	U-1470	Drug substance, Drug product	2020-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-002	8580765	2028-03-21	U-1470	Drug substance, Drug product	2020-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-002	8735372	2028-03-21	U-1470		2020-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-002	9085573	2028-03-21	U-1470	Drug substance, Drug product	2020-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-002	8334270*PED	2028-09-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-002	8580765*PED	2028-09-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-002	8735372*PED	2028-09-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-002	9085573*PED	2028-09-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-002	7964580	2029-03-26	U-1470	Drug substance, Drug product	2020-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-002	8633309	2029-03-26	U-1470	Drug substance, Drug product	2020-04-16	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 14 · 539 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N208341-001	ODE-293	2027-03-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-001	PED	2027-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-002	ODE-293	2027-03-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208341-002	PED	2027-09-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208341-001	ODE-293	2027-03-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208341-001	PED	2027-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208341-002	ODE-293	2027-03-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208341-002	PED	2027-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208341-001	ODE-293	2027-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208341-001	PED	2027-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208341-002	ODE-293	2027-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208341-002	PED	2027-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208341-001	M-277	2025-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208341-001	ODE-293	2027-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208341-001	PED	2027-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208341-002	M-277	2025-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208341-002	ODE-293	2027-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208341-002	PED	2027-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208341-001	M-277	2025-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208341-001	ODE-293	2027-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208341-001	PED	2027-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208341-002	M-277	2025-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208341-002	ODE-293	2027-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208341-002	PED	2027-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208341-001	M-277	2025-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208341-001	ODE-293	2027-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208341-001	PED	2027-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208341-001	ODE-376	2028-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208341-001	PED	2028-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208341-002	M-277	2025-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208341-002	ODE-293	2027-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208341-002	PED	2027-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208341-002	ODE-376	2028-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208341-002	PED	2028-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208341-001	M-277	2025-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208341-001	ODE-293	2027-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208341-001	PED	2027-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208341-001	ODE-376	2028-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208341-001	PED	2028-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208341-002	M-277	2025-04-27	`b8a1b40f171c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sofosbuvir and Velpatasvir	VELPATASVIR AND SOFOSBUVIR	Asegua Therapeutics LLC	d0c1a945-4440-4b5c-81aa-693ed3db597c	2025-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208341 application number: NDA208341 ndc (product): 72626-2701
Epclusa	VELPATASVIR AND SOFOSBUVIR	Gilead Sciences, Inc.	7f30631a-ee3b-4cfe-866b-964df3f0a44f	2024-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208341 application number: NDA208341 ndc (product): 61958-2203 ndc (product): 61958-2201

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 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61958-2201	Epclusa	Velpatasvir and Sofosbuvir	Gilead Sciences, Inc.	NDA	Current
61958-2201	Epclusa	Velpatasvir and Sofosbuvir	Gilead Sciences, Inc.	NDA	Current
61958-2201	Epclusa	Velpatasvir and Sofosbuvir	Gilead Sciences, Inc.	NDA	Current
61958-2201	Epclusa	Velpatasvir and Sofosbuvir	Gilead Sciences, Inc.	NDA	Current
61958-2201	Epclusa	Velpatasvir and Sofosbuvir	Gilead Sciences, Inc.	NDA	Current
61958-2201	Epclusa	Velpatasvir and Sofosbuvir	Gilead Sciences, Inc.	NDA	Current
61958-2201	Epclusa	Velpatasvir and Sofosbuvir	Gilead Sciences, Inc.	NDA	Current
61958-2201	Epclusa	Velpatasvir and Sofosbuvir	Gilead Sciences, Inc.	NDA	Current
61958-2201	Epclusa	Velpatasvir and Sofosbuvir	Gilead Sciences, Inc.	NDA	Current
61958-2203	Epclusa	Velpatasvir and Sofosbuvir	Gilead Sciences, Inc.	NDA	Current
61958-2203	Epclusa	Velpatasvir and Sofosbuvir	Gilead Sciences, Inc.	NDA	Current
61958-2203	Epclusa	Velpatasvir and Sofosbuvir	Gilead Sciences, Inc.	NDA	Current
61958-2203	Epclusa	Velpatasvir and Sofosbuvir	Gilead Sciences, Inc.	NDA	Current
61958-2203	Epclusa	Velpatasvir and Sofosbuvir	Gilead Sciences, Inc.	NDA	Current
61958-2203	Epclusa	Velpatasvir and Sofosbuvir	Gilead Sciences, Inc.	NDA	Current
72626-2701	Sofosbuvir and Velpatasvir	Velpatasvir and Sofosbuvir	Asegua Therapeutics LLC	NDA AUTHORIZED GENERIC	Current
72626-2701	Sofosbuvir and Velpatasvir	Velpatasvir and Sofosbuvir	Asegua Therapeutics LLC	NDA AUTHORIZED GENERIC	Current
72626-2701	Sofosbuvir and Velpatasvir	Velpatasvir and Sofosbuvir	Asegua Therapeutics LLC	NDA AUTHORIZED GENERIC	Current
72626-2701	Sofosbuvir and Velpatasvir	Velpatasvir and Sofosbuvir	Asegua Therapeutics LLC	NDA AUTHORIZED GENERIC	Current
72626-2701	Sofosbuvir and Velpatasvir	Velpatasvir and Sofosbuvir	Asegua Therapeutics LLC	NDA AUTHORIZED GENERIC	Current
72626-2701	Sofosbuvir and Velpatasvir	Velpatasvir and Sofosbuvir	Asegua Therapeutics LLC	NDA AUTHORIZED GENERIC	Current
72626-2701	Sofosbuvir and Velpatasvir	Velpatasvir and Sofosbuvir	Asegua Therapeutics LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73571	SUPPL	2023-02-21
70864	SUPPL	2022-04-29
70842	SUPPL	2022-04-28
67774	SUPPL	2021-06-14
67767	SUPPL	2021-06-11
63963	SUPPL	2020-07-20
63925	SUPPL	2020-07-15
62213	SUPPL	2020-03-20
62208	SUPPL	2020-03-20
60969	SUPPL	2019-11-19
60886	SUPPL	2019-11-19
60070	SUPPL	2019-09-20
60059	SUPPL	2019-09-20
50394	SUPPL	2017-11-13
50376	SUPPL	2017-11-13
49656	SUPPL	2017-09-01
49649	SUPPL	2017-09-01
49225	SUPPL	2017-08-03
49211	SUPPL	2017-08-02
47251	SUPPL	2017-02-16
47224	SUPPL	2017-02-15
44999	ORIG	2016-06-28
40632	ORIG	2016-06-28
32906	ORIG	2016-06-28