Application 205834

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	TABLET;ORAL	90MG;400MG	Yes	Yes
002	HARVONI	LEDIPASVIR; SOFOSBUVIR	TABLET;ORAL	45MG;200MG	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
N205834-001	HARVONI	LEDIPASVIR; SOFOSBUVIR	90MG;400MG	TABLET / ORAL		RLD, RS	2014-10-10
N205834-002	HARVONI	LEDIPASVIR; SOFOSBUVIR	45MG;200MG	TABLET / ORAL		RLD	2019-08-28

Orange Book patents#

Current patent rows page 1 of 1 · 67 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205834-001	8334270	2028-03-21	U-1470	Drug substance, Drug product	2014-10-30
N205834-001	8580765	2028-03-21	U-1470	Drug substance, Drug product	2014-10-30
N205834-001	8735372	2028-03-21	U-1470		2014-10-30
N205834-001	9085573	2028-03-21	U-1470	Drug substance, Drug product	2015-08-11
N205834-001	8334270*PED	2028-09-21		Pediatric extension
N205834-001	8580765*PED	2028-09-21		Pediatric extension
N205834-001	8735372*PED	2028-09-21		Pediatric extension
N205834-001	9085573*PED	2028-09-21		Pediatric extension
N205834-001	7964580	2029-03-26	U-1470	Drug substance, Drug product	2014-10-30
N205834-001	8633309	2029-03-26	U-1470	Drug substance, Drug product	2014-10-30
N205834-001	8889159	2029-03-26	U-1470	Drug product	2014-12-11
N205834-001	7964580*PED	2029-09-26		Pediatric extension
N205834-001	8633309*PED	2029-09-26		Pediatric extension
N205834-001	8889159*PED	2029-09-26		Pediatric extension
N205834-001	8088368	2030-05-12		Drug substance, Drug product	2014-10-30
N205834-001	8273341	2030-05-12	U-1470		2014-10-30
N205834-001	8822430	2030-05-12	U-1470	Drug substance, Drug product	2014-10-30
N205834-001	8841278	2030-05-12	U-1470	Drug product	2014-10-30
N205834-001	9511056	2030-05-12	U-1470	Drug product	2017-01-05
N205834-001	9284342	2030-09-13	U-1470	Drug substance, Drug product	2016-04-12
N205834-001	8088368*PED	2030-11-12		Pediatric extension
N205834-001	8273341*PED	2030-11-12		Pediatric extension
N205834-001	8822430*PED	2030-11-12		Pediatric extension
N205834-001	8841278*PED	2030-11-12		Pediatric extension
N205834-001	9511056*PED	2030-11-12		Pediatric extension
N205834-001	8618076	2030-12-11	U-1470	Drug substance, Drug product	2014-10-30
N205834-001	9284342*PED	2031-03-13		Pediatric extension
N205834-001	8618076*PED	2031-06-11		Pediatric extension
N205834-001	10456414	2032-09-14		Drug product	2019-11-20
N205834-001	9393256	2032-09-14	U-1470		2016-08-15
N205834-001	9393256*PED	2033-03-14		Pediatric extension
N205834-001	10039779	2034-01-30	U-2369	Drug substance, Drug product	2018-08-29
N205834-001	10039779	2034-01-30	U-2370	Drug substance, Drug product	2018-08-29
N205834-001	10039779*PED	2034-07-30		Pediatric extension
N205834-002	8334270	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23
N205834-002	8580765	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23
N205834-002	8735372	2028-03-21	U-1470		2019-09-23
N205834-002	9085573	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23
N205834-002	8334270*PED	2028-09-21		Pediatric extension
N205834-002	8580765*PED	2028-09-21		Pediatric extension
N205834-002	8735372*PED	2028-09-21		Pediatric extension
N205834-002	9085573*PED	2028-09-21		Pediatric extension
N205834-002	7964580	2029-03-26	U-1470	Drug substance, Drug product	2019-09-23
N205834-002	8633309	2029-03-26	U-1470	Drug substance, Drug product	2019-09-23
N205834-002	8889159	2029-03-26	U-1470	Drug product	2019-09-23
N205834-002	7964580*PED	2029-09-26		Pediatric extension
N205834-002	8633309*PED	2029-09-26		Pediatric extension
N205834-002	8889159*PED	2029-09-26		Pediatric extension
N205834-002	8088368	2030-05-12		Drug substance, Drug product	2019-09-23
N205834-002	8273341	2030-05-12	U-1470		2019-09-23
N205834-002	8822430	2030-05-12	U-1470	Drug substance, Drug product	2019-09-23
N205834-002	8841278	2030-05-12	U-1470	Drug product	2019-09-23
N205834-002	9511056	2030-05-12	U-1470		2019-09-23
N205834-002	9284342	2030-09-13	U-1470	Drug substance, Drug product	2019-09-23
N205834-002	8088368*PED	2030-11-12		Pediatric extension
N205834-002	8273341*PED	2030-11-12		Pediatric extension
N205834-002	8822430*PED	2030-11-12		Pediatric extension
N205834-002	8841278*PED	2030-11-12		Pediatric extension
N205834-002	9511056*PED	2030-11-12		Pediatric extension
N205834-002	8618076	2030-12-11	U-1470	Drug substance, Drug product	2019-09-23
N205834-002	9284342*PED	2031-03-13		Pediatric extension
N205834-002	8618076*PED	2031-06-11		Pediatric extension
N205834-002	10456414	2032-09-14		Drug product	2019-11-20
N205834-002	9393256	2032-09-14	U-1470		2019-09-23
N205834-002	9393256*PED	2033-03-14		Pediatric extension
N205834-002	10039779	2034-01-30	U-1470	Drug substance, Drug product	2019-09-23
N205834-002	10039779*PED	2034-07-30		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
N205834-001	ODE*	2026-08-28
N205834-002	ODE*	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 3 · 85 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	N205834-001	HARVONI	90MG;400MG	TABLET / ORAL	RLD, RS	2014-10-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-002	HARVONI	45MG;200MG	TABLET / ORAL	RLD	2019-08-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205834-001	HARVONI	90MG;400MG	TABLET / ORAL	RLD, RS	2014-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205834-002	HARVONI	45MG;200MG	TABLET / ORAL	RLD	2019-08-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205834-001	HARVONI	90MG;400MG	TABLET / ORAL	RLD, RS	2014-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205834-002	HARVONI	45MG;200MG	TABLET / ORAL	RLD	2019-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205834-001	HARVONI	90MG;400MG	TABLET / ORAL	RLD, RS	2014-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205834-002	HARVONI	45MG;200MG	TABLET / ORAL	RLD	2019-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205834-001	HARVONI	90MG;400MG	TABLET / ORAL	RLD, RS	2014-10-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205834-002	HARVONI	45MG;200MG	TABLET / ORAL	RLD	2019-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205834-001	HARVONI	90MG;400MG	TABLET / ORAL	RLD, RS	2014-10-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205834-002	HARVONI	45MG;200MG	TABLET / ORAL	RLD	2019-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205834-001	HARVONI	90MG;400MG	TABLET / ORAL	RLD, RS	2014-10-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205834-002	HARVONI	45MG;200MG	TABLET / ORAL	RLD	2019-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205834-001	HARVONI	90MG;400MG	TABLET / ORAL	RLD, RS	2014-10-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205834-002	HARVONI	45MG;200MG	TABLET / ORAL	RLD	2019-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205834-001	HARVONI	90MG;400MG	TABLET / ORAL	RLD, RS	2014-10-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205834-002	HARVONI	45MG;200MG	TABLET / ORAL	RLD	2019-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205834-001	HARVONI	90MG;400MG	TABLET / ORAL	RLD, RS	2014-10-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205834-002	HARVONI	45MG;200MG	TABLET / ORAL	RLD	2019-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205834-001	HARVONI	90MG;400MG	TABLET / ORAL	RLD, RS	2014-10-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205834-002	HARVONI	45MG;200MG	TABLET / ORAL	RLD	2019-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205834-001	HARVONI	90MG;400MG	TABLET / ORAL	RLD, RS	2014-10-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205834-002	HARVONI	45MG;200MG	TABLET / ORAL	RLD	2019-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205834-001	HARVONI	90MG;400MG	TABLET / ORAL	RLD, RS	2014-10-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205834-002	HARVONI	45MG;200MG	TABLET / ORAL	RLD	2019-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205834-001	HARVONI	90MG;400MG	TABLET / ORAL	RLD, RS	2014-10-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205834-002	HARVONI	45MG;200MG	TABLET / ORAL	RLD	2019-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205834-001	HARVONI	90MG;400MG	TABLET / ORAL	RLD, RS	2014-10-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205834-002	HARVONI	45MG;200MG	TABLET / ORAL	RLD	2019-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205834-001	HARVONI	90MG;400MG	TABLET / ORAL	RLD, RS	2014-10-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N205834-002	HARVONI	45MG;200MG	TABLET / ORAL	RLD	2019-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205834-001	HARVONI	90MG;400MG	TABLET / ORAL	RLD, RS	2014-10-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205834-002	HARVONI	45MG;200MG	TABLET / ORAL	RLD	2019-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205834-001	HARVONI	90MG;400MG	TABLET / ORAL	RLD, RS	2014-10-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205834-002	HARVONI	45MG;200MG	TABLET / ORAL	RLD	2019-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205834-001	HARVONI	90MG;400MG	TABLET / ORAL	RLD, RS	2014-10-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205834-002	HARVONI	45MG;200MG	TABLET / ORAL	RLD	2019-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205834-001	HARVONI	90MG;400MG	TABLET / ORAL	RLD, RS	2014-10-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205834-002	HARVONI	45MG;200MG	TABLET / ORAL	RLD	2019-08-28	`74a2ff9319b5…`

Observed Orange Book patent history#

Patent history page 1 of 70 · 2,795 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	N205834-001	8334270	2028-03-21	U-1470	Drug substance, Drug product	2014-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	8580765	2028-03-21	U-1470	Drug substance, Drug product	2014-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	8735372	2028-03-21	U-1470		2014-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	9085573	2028-03-21	U-1470	Drug substance, Drug product	2015-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	8334270*PED	2028-09-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	8580765*PED	2028-09-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	8735372*PED	2028-09-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	9085573*PED	2028-09-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	7964580	2029-03-26	U-1470	Drug substance, Drug product	2014-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	8633309	2029-03-26	U-1470	Drug substance, Drug product	2014-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	8889159	2029-03-26	U-1470	Drug product	2014-12-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	7964580*PED	2029-09-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	8633309*PED	2029-09-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	8889159*PED	2029-09-26		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	8088368	2030-05-12		Drug substance, Drug product	2014-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	8273341	2030-05-12	U-1470		2014-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	8822430	2030-05-12	U-1470	Drug substance, Drug product	2014-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	8841278	2030-05-12	U-1470	Drug product	2014-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	9511056	2030-05-12	U-1470	Drug product	2017-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	9284342	2030-09-13	U-1470	Drug substance, Drug product	2016-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	8088368*PED	2030-11-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	8273341*PED	2030-11-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	8822430*PED	2030-11-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	8841278*PED	2030-11-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	9511056*PED	2030-11-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	8618076	2030-12-11	U-1470	Drug substance, Drug product	2014-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	9284342*PED	2031-03-13		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	8618076*PED	2031-06-11		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	10456414	2032-09-14		Drug product	2019-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	9393256	2032-09-14	U-1470		2016-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	9393256*PED	2033-03-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	10039779	2034-01-30	U-2369	Drug substance, Drug product	2018-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	10039779	2034-01-30	U-2370	Drug substance, Drug product	2018-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-001	10039779*PED	2034-07-30		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-002	8334270	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-002	8580765	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-002	8735372	2028-03-21	U-1470		2019-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-002	9085573	2028-03-21	U-1470	Drug substance, Drug product	2019-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-002	8334270*PED	2028-09-21		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-002	8580765*PED	2028-09-21		Pediatric extension		`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 283 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	N205834-001	ODE*	2026-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205834-002	ODE*	2026-08-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205834-001	ODE*	2026-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205834-002	ODE*	2026-08-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205834-001	ODE*	2026-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205834-002	ODE*	2026-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205834-001	ODE*	2026-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205834-002	ODE*	2026-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205834-001	ODE*	2026-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205834-002	ODE*	2026-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205834-001	ODE*	2026-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205834-002	ODE*	2026-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205834-001	ODE*	2026-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205834-002	ODE*	2026-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205834-001	ODE-136	2024-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205834-001	PED	2024-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205834-001	ODE*	2026-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205834-002	ODE*	2024-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205834-002	PED	2024-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205834-002	ODE*	2026-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205834-001	ODE-136	2024-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205834-001	PED	2024-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205834-001	ODE*	2026-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205834-002	ODE*	2024-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205834-002	PED	2024-10-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205834-002	ODE*	2026-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205834-001	ODE-136	2024-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205834-001	PED	2024-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205834-001	ODE*	2026-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205834-002	ODE*	2024-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205834-002	PED	2024-10-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205834-002	ODE*	2026-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205834-001	ODE-136	2024-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205834-001	PED	2024-10-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205834-001	ODE*	2026-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205834-002	ODE*	2024-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205834-002	PED	2024-10-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205834-002	ODE*	2026-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205834-001	ODE-136	2024-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205834-001	PED	2024-10-07	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ledipasvir and Sofosbuvir	LEDIPASVIR AND SOFOSBUVIR	Asegua Therapeutics LLC	46f4a73b-0cd6-4902-9092-3ac79e882c1a	2025-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 205834 application number: NDA205834 ndc (product): 72626-2601
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): 205834 application number: NDA205834 ndc (product): 61958-1803 ndc (product): 61958-1801

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61958-1801	Harvoni	LEDIPASVIR and SOFOSBUVIR	Gilead Sciences, Inc	NDA	Current
61958-1801	Harvoni	LEDIPASVIR and SOFOSBUVIR	Gilead Sciences, Inc	NDA	Current
61958-1801	Harvoni	LEDIPASVIR and SOFOSBUVIR	Gilead Sciences, Inc	NDA	Current
61958-1801	Harvoni	LEDIPASVIR and SOFOSBUVIR	Gilead Sciences, Inc	NDA	Current
61958-1801	Harvoni	LEDIPASVIR and SOFOSBUVIR	Gilead Sciences, Inc	NDA	Current
61958-1801	Harvoni	LEDIPASVIR and SOFOSBUVIR	Gilead Sciences, Inc	NDA	Current
61958-1801	Harvoni	LEDIPASVIR and SOFOSBUVIR	Gilead Sciences, Inc	NDA	Current
61958-1803	Harvoni	ledipasvir and sofosbuvir	Gilead Sciences, Inc	NDA	Current
61958-1803	Harvoni	ledipasvir and sofosbuvir	Gilead Sciences, Inc	NDA	Current
61958-1803	Harvoni	ledipasvir and sofosbuvir	Gilead Sciences, Inc	NDA	Current
61958-1803	Harvoni	ledipasvir and sofosbuvir	Gilead Sciences, Inc	NDA	Current
61958-1803	Harvoni	ledipasvir and sofosbuvir	Gilead Sciences, Inc	NDA	Current
61958-1803	Harvoni	ledipasvir and sofosbuvir	Gilead Sciences, Inc	NDA	Current
72626-2601	Ledipasvir and Sofosbuvir	Ledipasvir and Sofosbuvir	Asegua Therapeutics LLC	NDA AUTHORIZED GENERIC	Current
72626-2601	Ledipasvir and Sofosbuvir	Ledipasvir and Sofosbuvir	Asegua Therapeutics LLC	NDA AUTHORIZED GENERIC	Current
72626-2601	Ledipasvir and Sofosbuvir	Ledipasvir and Sofosbuvir	Asegua Therapeutics LLC	NDA AUTHORIZED GENERIC	Current
72626-2601	Ledipasvir and Sofosbuvir	Ledipasvir and Sofosbuvir	Asegua Therapeutics LLC	NDA AUTHORIZED GENERIC	Current
72626-2601	Ledipasvir and Sofosbuvir	Ledipasvir and Sofosbuvir	Asegua Therapeutics LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80685	SUPPL	2024-12-23
80666	SUPPL	2024-12-20
62079	SUPPL	2020-03-09
62074	SUPPL	2020-03-06
60967	SUPPL	2019-11-19
60887	SUPPL	2019-11-19
60068	SUPPL	2019-09-20
60060	SUPPL	2019-09-20
59885	SUPPL	2019-08-30
59872	SUPPL	2019-08-29
50393	SUPPL	2017-11-13
50375	SUPPL	2017-11-13
47980	SUPPL	2017-04-12
47920	SUPPL	2017-04-10
47218	SUPPL	2017-02-15
47213	SUPPL	2017-02-15
40513	SUPPL	2016-06-13
32744	SUPPL	2016-06-09
32745	SUPPL	2016-03-31
40514	SUPPL	2016-03-30
44934	SUPPL	2016-03-03
44933	SUPPL	2016-03-03
24508	SUPPL	2016-03-03
40512	SUPPL	2016-02-25
40511	SUPPL	2016-02-25
19690	SUPPL	2016-02-25
32743	SUPPL	2016-02-16
10514	SUPPL	2016-02-16
10513	SUPPL	2016-02-16
40510	SUPPL	2015-11-19
40509	SUPPL	2015-11-19
40508	SUPPL	2015-11-19
40507	SUPPL	2015-11-19
19689	SUPPL	2015-11-19
32742	SUPPL	2015-11-16
32741	SUPPL	2015-11-16
10512	SUPPL	2015-11-16
10511	SUPPL	2015-11-16
10510	SUPPL	2015-11-16
40506	SUPPL	2015-03-24
32740	SUPPL	2015-03-24
44932	ORIG	2014-11-03
43504	ORIG	2014-11-03
40505	ORIG	2014-10-15
10509	ORIG	2014-10-14
64115	ORIG	1900-01-01
64114	ORIG	1900-01-01
64113	ORIG	1900-01-01
64112	ORIG	1900-01-01
51287	SUPPL	1900-01-01
51286	SUPPL	1900-01-01
51285	SUPPL	1900-01-01