Application 212480

Type: NDA
Sponsor: GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SOVALDI	SOFOSBUVIR	PELLETS;ORAL	150MG/PACKET	Yes	No
002	SOVALDI	SOFOSBUVIR	PELLETS;ORAL	200MG/PACKET	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
N212480-001	SOVALDI	SOFOSBUVIR	150MG/PACKET	PELLETS / ORAL		RLD	2019-08-28
N212480-002	SOVALDI	SOFOSBUVIR	200MG/PACKET	PELLETS / ORAL		RLD, RS	2019-08-28

Orange Book patents#

Current patent rows page 1 of 1 · 32 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212480-001	8334270	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23
N212480-001	8580765	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23
N212480-001	9085573	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23
N212480-001	8334270*PED	2028-09-21		Pediatric extension
N212480-001	8580765*PED	2028-09-21		Pediatric extension
N212480-001	9085573*PED	2028-09-21		Pediatric extension
N212480-001	7964580	2029-03-26	U-1470	Drug substance, Drug product	2019-09-23
N212480-001	8633309	2029-03-26	U-1470	Drug substance, Drug product	2019-09-23
N212480-001	8889159	2029-03-26	U-1470	Drug product	2019-09-23
N212480-001	7964580*PED	2029-09-26		Pediatric extension
N212480-001	8633309*PED	2029-09-26		Pediatric extension
N212480-001	8889159*PED	2029-09-26		Pediatric extension
N212480-001	9284342	2030-09-13	U-1470	Drug substance, Drug product	2019-09-23
N212480-001	8618076	2030-12-11	U-1470	Drug substance, Drug product	2019-09-23
N212480-001	9284342*PED	2031-03-13		Pediatric extension
N212480-001	8618076*PED	2031-06-11		Pediatric extension
N212480-002	8334270	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23
N212480-002	8580765	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23
N212480-002	9085573	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23
N212480-002	8334270*PED	2028-09-21		Pediatric extension
N212480-002	8580765*PED	2028-09-21		Pediatric extension
N212480-002	9085573*PED	2028-09-21		Pediatric extension
N212480-002	7964580	2029-03-26	U-1470	Drug substance, Drug product	2019-09-23
N212480-002	8633309	2029-03-26	U-1470	Drug substance, Drug product	2019-09-23
N212480-002	8889159	2029-03-26	U-1470	Drug product	2019-09-23
N212480-002	7964580*PED	2029-09-26		Pediatric extension
N212480-002	8633309*PED	2029-09-26		Pediatric extension
N212480-002	8889159*PED	2029-09-26		Pediatric extension
N212480-002	9284342	2030-09-13	U-1470	Drug substance, Drug product	2019-09-23
N212480-002	8618076	2030-12-11	U-1470	Drug substance, Drug product	2019-09-23
N212480-002	9284342*PED	2031-03-13		Pediatric extension
N212480-002	8618076*PED	2031-06-11		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212480-001	ODE-258	2026-08-28
N212480-002	ODE-258	2026-08-28

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 · 80 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	N212480-001	SOVALDI	150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-002	SOVALDI	200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212480-001	SOVALDI	150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212480-002	SOVALDI	200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212480-001	SOVALDI	150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212480-002	SOVALDI	200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212480-001	SOVALDI	150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212480-002	SOVALDI	200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212480-001	SOVALDI	150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212480-002	SOVALDI	200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212480-001	SOVALDI	150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212480-002	SOVALDI	200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212480-001	SOVALDI	150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212480-002	SOVALDI	200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212480-001	SOVALDI	150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212480-002	SOVALDI	200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212480-001	SOVALDI	150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212480-002	SOVALDI	200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212480-001	SOVALDI	150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212480-002	SOVALDI	200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212480-001	SOVALDI	150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212480-002	SOVALDI	200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212480-001	SOVALDI	150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212480-002	SOVALDI	200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212480-001	SOVALDI	150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212480-002	SOVALDI	200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212480-001	SOVALDI	150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212480-002	SOVALDI	200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212480-001	SOVALDI	150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212480-002	SOVALDI	200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212480-001	SOVALDI	150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212480-002	SOVALDI	200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212480-001	SOVALDI	150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212480-002	SOVALDI	200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N212480-001	SOVALDI	150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N212480-002	SOVALDI	200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N212480-001	SOVALDI	150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212480-002	SOVALDI	200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212480-001	SOVALDI	150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N212480-002	SOVALDI	200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 32 · 1,248 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	N212480-001	8334270	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-001	8580765	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-001	9085573	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-001	8334270*PED	2028-09-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-001	8580765*PED	2028-09-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-001	9085573*PED	2028-09-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-001	7964580	2029-03-26	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-001	8633309	2029-03-26	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-001	8889159	2029-03-26	U-1470	Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-001	7964580*PED	2029-09-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-001	8633309*PED	2029-09-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-001	8889159*PED	2029-09-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-001	9284342	2030-09-13	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-001	8618076	2030-12-11	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-001	9284342*PED	2031-03-13		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-001	8618076*PED	2031-06-11		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-002	8334270	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-002	8580765	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-002	9085573	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-002	8334270*PED	2028-09-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-002	8580765*PED	2028-09-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-002	9085573*PED	2028-09-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-002	7964580	2029-03-26	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-002	8633309	2029-03-26	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-002	8889159	2029-03-26	U-1470	Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-002	7964580*PED	2029-09-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-002	8633309*PED	2029-09-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-002	8889159*PED	2029-09-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-002	9284342	2030-09-13	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-002	8618076	2030-12-11	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-002	9284342*PED	2031-03-13		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-002	8618076*PED	2031-06-11		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212480-001	8334270	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212480-001	8580765	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212480-001	9085573	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212480-001	8334270*PED	2028-09-21		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212480-001	8580765*PED	2028-09-21		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212480-001	9085573*PED	2028-09-21		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212480-001	7964580	2029-03-26	U-1470	Drug substance, Drug product	2019-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212480-001	8633309	2029-03-26	U-1470	Drug substance, Drug product	2019-09-23	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 182 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	N212480-001	ODE-258	2026-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212480-002	ODE-258	2026-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212480-001	ODE-258	2026-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212480-002	ODE-258	2026-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212480-001	ODE-258	2026-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212480-002	ODE-258	2026-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212480-001	ODE-258	2026-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212480-002	ODE-258	2026-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212480-001	ODE-258	2026-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212480-002	ODE-258	2026-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212480-001	ODE*	2024-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212480-001	PED	2024-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212480-001	ODE-258	2026-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212480-002	ODE*	2024-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212480-002	PED	2024-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212480-002	ODE-258	2026-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212480-001	ODE*	2024-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212480-001	PED	2024-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212480-001	ODE-258	2026-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212480-002	ODE*	2024-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212480-002	PED	2024-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212480-002	ODE-258	2026-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212480-001	ODE*	2024-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212480-001	PED	2024-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212480-001	ODE-258	2026-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212480-002	ODE*	2024-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212480-002	PED	2024-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212480-002	ODE-258	2026-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212480-001	ODE*	2024-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212480-001	PED	2024-10-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212480-001	ODE-258	2026-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212480-002	ODE*	2024-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212480-002	PED	2024-10-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212480-002	ODE-258	2026-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212480-001	ODE*	2024-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212480-001	PED	2024-10-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212480-001	ODE-258	2026-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212480-002	ODE*	2024-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212480-002	PED	2024-10-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212480-002	ODE-258	2026-08-28	`d06236e962d9…`

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
Sovaldi	SOFOSBUVIR	Gilead Sciences, Inc.	80beab2c-396e-4a37-a4dc-40fdb62859cf	2024-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 212480 application number: NDA212480 ndc (product): 61958-1504 ndc (product): 61958-1505

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61958-1504	Sovaldi	SOFOSBUVIR	Gilead Sciences, Inc.	NDA	Current
61958-1504	Sovaldi	SOFOSBUVIR	Gilead Sciences, Inc.	NDA	Current
61958-1504	Sovaldi	SOFOSBUVIR	Gilead Sciences, Inc.	NDA	Current
61958-1504	Sovaldi	SOFOSBUVIR	Gilead Sciences, Inc.	NDA	Current
61958-1505	Sovaldi	SOFOSBUVIR	Gilead Sciences, Inc.	NDA	Current
61958-1505	Sovaldi	SOFOSBUVIR	Gilead Sciences, Inc.	NDA	Current
61958-1505	Sovaldi	SOFOSBUVIR	Gilead Sciences, Inc.	NDA	Current
61958-1505	Sovaldi	SOFOSBUVIR	Gilead Sciences, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80749	SUPPL	2024-12-27
80743	SUPPL	2024-12-27
62299	ORIG	2020-03-24
62077	SUPPL	2020-03-06
62061	SUPPL	2020-03-06
61159	SUPPL	2019-12-05
60067	SUPPL	2019-09-20
60064	SUPPL	2019-09-20
59888	ORIG	2019-08-30
59873	ORIG	2019-08-29