Application 212477

Type: NDA
Sponsor: GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HARVONI	LEDIPASVIR; SOFOSBUVIR	PELLETS;ORAL	33.75MG;150MG/PACKET	Yes	No
002	HARVONI	LEDIPASVIR; SOFOSBUVIR	PELLETS;ORAL	45MG;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
N212477-001	HARVONI	LEDIPASVIR; SOFOSBUVIR	33.75MG;150MG/PACKET	PELLETS / ORAL		RLD	2019-08-28
N212477-002	HARVONI	LEDIPASVIR; SOFOSBUVIR	45MG;200MG/PACKET	PELLETS / ORAL		RLD, RS	2019-08-28

Orange Book patents#

Current patent rows page 1 of 1 · 62 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212477-001	8334270	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23
N212477-001	8580765	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23
N212477-001	8735372	2028-03-21	U-1470		2019-09-23
N212477-001	9085573	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23
N212477-001	8334270*PED	2028-09-21		Pediatric extension
N212477-001	8580765*PED	2028-09-21		Pediatric extension
N212477-001	8735372*PED	2028-09-21		Pediatric extension
N212477-001	9085573*PED	2028-09-21		Pediatric extension
N212477-001	7964580	2029-03-26	U-1470	Drug substance, Drug product	2019-09-23
N212477-001	8633309	2029-03-26	U-1470	Drug substance, Drug product	2019-09-23
N212477-001	8889159	2029-03-26	U-1470	Drug product	2019-09-23
N212477-001	7964580*PED	2029-09-26		Pediatric extension
N212477-001	8633309*PED	2029-09-26		Pediatric extension
N212477-001	8889159*PED	2029-09-26		Pediatric extension
N212477-001	8088368	2030-05-12		Drug substance, Drug product	2019-09-23
N212477-001	8273341	2030-05-12	U-1470		2019-09-23
N212477-001	8822430	2030-05-12	U-1470	Drug substance, Drug product	2019-09-23
N212477-001	8841278	2030-05-12	U-1470	Drug product	2019-09-23
N212477-001	9511056	2030-05-12	U-1470		2019-09-23
N212477-001	9284342	2030-09-13	U-1470	Drug substance, Drug product	2019-09-23
N212477-001	8088368*PED	2030-11-12		Pediatric extension
N212477-001	8273341*PED	2030-11-12		Pediatric extension
N212477-001	8822430*PED	2030-11-12		Pediatric extension
N212477-001	8841278*PED	2030-11-12		Pediatric extension
N212477-001	9511056*PED	2030-11-12		Pediatric extension
N212477-001	8618076	2030-12-11	U-1470	Drug substance, Drug product	2019-09-23
N212477-001	9284342*PED	2031-03-13		Pediatric extension
N212477-001	8618076*PED	2031-06-11		Pediatric extension
N212477-001	10456414	2032-09-14		Drug product	2019-11-20
N212477-001	9393256	2032-09-14	U-1470		2019-09-23
N212477-001	9393256*PED	2033-03-14		Pediatric extension
N212477-002	8334270	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23
N212477-002	8580765	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23
N212477-002	8735372	2028-03-21	U-1470		2019-09-23
N212477-002	9085573	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23
N212477-002	8334270*PED	2028-09-21		Pediatric extension
N212477-002	8580765*PED	2028-09-21		Pediatric extension
N212477-002	8735372*PED	2028-09-21		Pediatric extension
N212477-002	9085573*PED	2028-09-21		Pediatric extension
N212477-002	7964580	2029-03-26	U-1470	Drug substance, Drug product	2019-09-23
N212477-002	8633309	2029-03-26	U-1470	Drug substance, Drug product	2019-09-23
N212477-002	8889159	2029-03-26	U-1470	Drug product	2019-09-23
N212477-002	7964580*PED	2029-09-26		Pediatric extension
N212477-002	8633309*PED	2029-09-26		Pediatric extension
N212477-002	8889159*PED	2029-09-26		Pediatric extension
N212477-002	8088368	2030-05-12		Drug substance, Drug product	2019-09-23
N212477-002	8273341	2030-05-12	U-1470		2019-09-23
N212477-002	8822430	2030-05-12	U-1470	Drug substance, Drug product	2019-09-23
N212477-002	8841278	2030-05-12	U-1470	Drug product	2019-09-23
N212477-002	9511056	2030-05-12	U-1470		2019-09-23
N212477-002	9284342	2030-09-13	U-1470	Drug substance, Drug product	2019-09-23
N212477-002	8088368*PED	2030-11-12		Pediatric extension
N212477-002	8273341*PED	2030-11-12		Pediatric extension
N212477-002	8822430*PED	2030-11-12		Pediatric extension
N212477-002	8841278*PED	2030-11-12		Pediatric extension
N212477-002	9511056*PED	2030-11-12		Pediatric extension
N212477-002	8618076	2030-12-11	U-1470	Drug substance, Drug product	2019-09-23
N212477-002	9284342*PED	2031-03-13		Pediatric extension
N212477-002	8618076*PED	2031-06-11		Pediatric extension
N212477-002	10456414	2032-09-14		Drug product	2019-11-20
N212477-002	9393256	2032-09-14	U-1470		2019-09-23
N212477-002	9393256*PED	2033-03-14		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212477-001	ODE-262	2026-08-28
N212477-001	ODE-263	2026-08-28
N212477-001	ODE-264	2026-08-28
N212477-002	ODE-262	2026-08-28
N212477-002	ODE-263	2026-08-28
N212477-002	ODE-264	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	N212477-001	HARVONI	33.75MG;150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-002	HARVONI	45MG;200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212477-001	HARVONI	33.75MG;150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212477-002	HARVONI	45MG;200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212477-001	HARVONI	33.75MG;150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212477-002	HARVONI	45MG;200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212477-001	HARVONI	33.75MG;150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212477-002	HARVONI	45MG;200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212477-001	HARVONI	33.75MG;150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212477-002	HARVONI	45MG;200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212477-001	HARVONI	33.75MG;150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212477-002	HARVONI	45MG;200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212477-001	HARVONI	33.75MG;150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212477-002	HARVONI	45MG;200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212477-001	HARVONI	33.75MG;150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212477-002	HARVONI	45MG;200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212477-001	HARVONI	33.75MG;150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212477-002	HARVONI	45MG;200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212477-001	HARVONI	33.75MG;150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212477-002	HARVONI	45MG;200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212477-001	HARVONI	33.75MG;150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212477-002	HARVONI	45MG;200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212477-001	HARVONI	33.75MG;150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212477-002	HARVONI	45MG;200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212477-001	HARVONI	33.75MG;150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212477-002	HARVONI	45MG;200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212477-001	HARVONI	33.75MG;150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212477-002	HARVONI	45MG;200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212477-001	HARVONI	33.75MG;150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212477-002	HARVONI	45MG;200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212477-001	HARVONI	33.75MG;150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212477-002	HARVONI	45MG;200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212477-001	HARVONI	33.75MG;150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212477-002	HARVONI	45MG;200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N212477-001	HARVONI	33.75MG;150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N212477-002	HARVONI	45MG;200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N212477-001	HARVONI	33.75MG;150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212477-002	HARVONI	45MG;200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212477-001	HARVONI	33.75MG;150MG/PACKET	PELLETS / ORAL	RLD	2019-08-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N212477-002	HARVONI	45MG;200MG/PACKET	PELLETS / ORAL	RLD, RS	2019-08-28	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 61 · 2,416 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	N212477-001	8334270	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	8580765	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	8735372	2028-03-21	U-1470		2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	9085573	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	8334270*PED	2028-09-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	8580765*PED	2028-09-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	8735372*PED	2028-09-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	9085573*PED	2028-09-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	7964580	2029-03-26	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	8633309	2029-03-26	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	8889159	2029-03-26	U-1470	Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	7964580*PED	2029-09-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	8633309*PED	2029-09-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	8889159*PED	2029-09-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	8088368	2030-05-12		Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	8273341	2030-05-12	U-1470		2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	8822430	2030-05-12	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	8841278	2030-05-12	U-1470	Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	9511056	2030-05-12	U-1470		2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	9284342	2030-09-13	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	8088368*PED	2030-11-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	8273341*PED	2030-11-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	8822430*PED	2030-11-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	8841278*PED	2030-11-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	9511056*PED	2030-11-12		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	8618076	2030-12-11	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	9284342*PED	2031-03-13		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	8618076*PED	2031-06-11		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	10456414	2032-09-14		Drug product	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	9393256	2032-09-14	U-1470		2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	9393256*PED	2033-03-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-002	8334270	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-002	8580765	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-002	8735372	2028-03-21	U-1470		2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-002	9085573	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-002	8334270*PED	2028-09-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-002	8580765*PED	2028-09-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-002	8735372*PED	2028-09-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-002	9085573*PED	2028-09-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-002	7964580	2029-03-26	U-1470	Drug substance, Drug product	2019-09-23	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 7 · 262 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	N212477-001	ODE-262	2026-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	ODE-263	2026-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-001	ODE-264	2026-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-002	ODE-262	2026-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-002	ODE-263	2026-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212477-002	ODE-264	2026-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212477-001	ODE-262	2026-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212477-001	ODE-263	2026-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212477-001	ODE-264	2026-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212477-002	ODE-262	2026-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212477-002	ODE-263	2026-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212477-002	ODE-264	2026-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212477-001	ODE-262	2026-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212477-001	ODE-263	2026-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212477-001	ODE-264	2026-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212477-002	ODE-262	2026-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212477-002	ODE-263	2026-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212477-002	ODE-264	2026-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212477-001	ODE-262	2026-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212477-001	ODE-263	2026-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212477-001	ODE-264	2026-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212477-002	ODE-262	2026-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212477-002	ODE-263	2026-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212477-002	ODE-264	2026-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212477-001	ODE-262	2026-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212477-001	ODE-263	2026-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212477-001	ODE-264	2026-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212477-002	ODE-262	2026-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212477-002	ODE-263	2026-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212477-002	ODE-264	2026-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212477-001	ODE-262	2026-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212477-001	ODE-263	2026-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212477-001	ODE-264	2026-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212477-002	ODE-262	2026-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212477-002	ODE-263	2026-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212477-002	ODE-264	2026-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212477-001	ODE-262	2026-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212477-001	ODE-263	2026-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212477-001	ODE-264	2026-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212477-002	ODE-262	2026-08-28	`2680178bc6a6…`

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
Harvoni	LEDIPASVIR AND SOFOSBUVIR	Gilead Sciences, Inc	f4ec77e4-bae8-4db0-b3d5-bde09c5fa075	2024-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 212477 application number: NDA212477 ndc (product): 61958-1805 ndc (product): 61958-1804

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61958-1804	Harvoni	ledipasvir and sofosbuvir	Gilead Sciences, Inc	NDA	Current
61958-1804	Harvoni	ledipasvir and sofosbuvir	Gilead Sciences, Inc	NDA	Current
61958-1804	Harvoni	ledipasvir and sofosbuvir	Gilead Sciences, Inc	NDA	Current
61958-1804	Harvoni	ledipasvir and sofosbuvir	Gilead Sciences, Inc	NDA	Current
61958-1804	Harvoni	ledipasvir and sofosbuvir	Gilead Sciences, Inc	NDA	Current
61958-1804	Harvoni	ledipasvir and sofosbuvir	Gilead Sciences, Inc	NDA	Current
61958-1805	Harvoni	ledipasvir and sofosbuvir	Gilead Sciences, Inc	NDA	Current
61958-1805	Harvoni	ledipasvir and sofosbuvir	Gilead Sciences, Inc	NDA	Current
61958-1805	Harvoni	ledipasvir and sofosbuvir	Gilead Sciences, Inc	NDA	Current
61958-1805	Harvoni	ledipasvir and sofosbuvir	Gilead Sciences, Inc	NDA	Current
61958-1805	Harvoni	ledipasvir and sofosbuvir	Gilead Sciences, Inc	NDA	Current
61958-1805	Harvoni	ledipasvir and sofosbuvir	Gilead Sciences, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80686	SUPPL	2024-12-23
80667	SUPPL	2024-12-20
62686	ORIG	2020-04-27
62080	SUPPL	2020-03-09
62075	SUPPL	2020-03-06
61156	SUPPL	2019-12-05
60968	SUPPL	2019-11-19
60888	SUPPL	2019-11-19
60069	SUPPL	2019-09-20
60061	SUPPL	2019-09-20
59879	ORIG	2019-08-29
59871	ORIG	2019-08-29