Application 210251

Type: NDA
Sponsor: GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BIKTARVY	BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	TABLET;ORAL	EQ 50MG BASE;200MG;EQ 25MG BASE	Yes	Yes
002	BIKTARVY	BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	TABLET;ORAL	EQ 30MG BASE;120MG;EQ 15MG BASE	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
N210251-001	BIKTARVY	BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL		RLD, RS	2018-02-07
N210251-002	BIKTARVY	BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL		RLD	2021-10-07

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210251-001	8754065	2032-08-15	U-257	Drug substance, Drug product	2018-02-26
N210251-001	9296769	2032-08-15	U-257	Drug substance, Drug product	2018-02-26
N210251-001	8754065*PED	2033-02-15		Pediatric extension
N210251-001	9296769*PED	2033-02-15		Pediatric extension
N210251-001	9216996	2033-12-19		Drug substance, Drug product	2018-02-26
N210251-001	9732092	2033-12-19		Drug substance, Drug product	2018-02-26
N210251-001	10385067	2035-06-19	U-257		2019-08-30
N210251-001	9708342	2035-06-19		Drug substance, Drug product	2018-02-26
N210251-001	10548846	2036-11-08		Drug product	2020-02-28
N210251-001	11744802	2036-11-08		Drug product	2023-10-04
N210251-001	12594244	2036-11-08	U-257	Drug product	2026-04-30
N210251-002	8754065	2032-08-15	U-257	Drug substance, Drug product	2021-10-28
N210251-002	9296769	2032-08-15	U-257	Drug substance, Drug product	2021-10-28
N210251-002	8754065*PED	2033-02-15		Pediatric extension
N210251-002	9296769*PED	2033-02-15		Pediatric extension
N210251-002	9216996	2033-12-19		Drug substance, Drug product	2021-10-28
N210251-002	9732092	2033-12-19		Drug substance, Drug product	2021-10-28
N210251-002	10385067	2035-06-19	U-257		2021-10-28
N210251-002	9708342	2035-06-19		Drug substance, Drug product	2021-10-28
N210251-002	12594244	2036-11-08	U-257	Drug product	2026-04-30

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 9 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N210251-001	ODE-256	2026-06-18
N210251-001	I-942	2027-02-23
N210251-001	M-305	2027-04-24
N210251-001	ODE-468	2031-02-23
N210251-001	ODE-540	2032-07-30
N210251-002	I-942	2027-02-23
N210251-002	ODE-378	2028-10-07
N210251-002	ODE-468	2031-02-23
N210251-002	ODE-540	2032-07-30

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 · 74 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	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210251-002	BIKTARVY	EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET / ORAL	RLD	2021-10-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210251-001	BIKTARVY	EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET / ORAL	RLD, RS	2018-02-07	`87673890dc5c…`

Observed Orange Book patent history#

Patent history page 1 of 19 · 755 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	N210251-001	8754065	2032-08-15	U-257	Drug substance, Drug product	2018-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-001	9296769	2032-08-15	U-257	Drug substance, Drug product	2018-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-001	8754065*PED	2033-02-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-001	9296769*PED	2033-02-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-001	9216996	2033-12-19		Drug substance, Drug product	2018-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-001	9732092	2033-12-19		Drug substance, Drug product	2018-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-001	10385067	2035-06-19	U-257		2019-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-001	9708342	2035-06-19		Drug substance, Drug product	2018-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-001	10548846	2036-11-08		Drug product	2020-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-001	11744802	2036-11-08		Drug product	2023-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-002	8754065	2032-08-15	U-257	Drug substance, Drug product	2021-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-002	9296769	2032-08-15	U-257	Drug substance, Drug product	2021-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-002	8754065*PED	2033-02-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-002	9296769*PED	2033-02-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-002	9216996	2033-12-19		Drug substance, Drug product	2021-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-002	9732092	2033-12-19		Drug substance, Drug product	2021-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-002	10385067	2035-06-19	U-257		2021-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-002	9708342	2035-06-19		Drug substance, Drug product	2021-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	7390791	2025-01-07		Drug substance, Drug product	2018-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	7390791*PED	2025-07-07		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	8754065	2032-08-15	U-257	Drug substance, Drug product	2018-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	9296769	2032-08-15	U-257	Drug substance, Drug product	2018-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	8754065*PED	2033-02-15		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	9296769*PED	2033-02-15		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	9216996	2033-12-19		Drug substance, Drug product	2018-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	9732092	2033-12-19		Drug substance, Drug product	2018-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	10385067	2035-06-19	U-257		2019-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	9708342	2035-06-19		Drug substance, Drug product	2018-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	10548846	2036-11-08		Drug product	2020-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	11744802	2036-11-08		Drug product	2023-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-002	7390791	2025-01-07		Drug substance, Drug product	2021-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-002	7390791*PED	2025-07-07		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-002	8754065	2032-08-15	U-257	Drug substance, Drug product	2021-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-002	9296769	2032-08-15	U-257	Drug substance, Drug product	2021-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-002	8754065*PED	2033-02-15		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-002	9296769*PED	2033-02-15		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-002	9216996	2033-12-19		Drug substance, Drug product	2021-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-002	9732092	2033-12-19		Drug substance, Drug product	2021-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-002	10385067	2035-06-19	U-257		2021-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-002	9708342	2035-06-19		Drug substance, Drug product	2021-10-28	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 233 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	N210251-001	ODE-256	2026-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-001	I-942	2027-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-001	M-305	2027-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-001	ODE-468	2031-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-002	I-942	2027-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-002	ODE-378	2028-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210251-002	ODE-468	2031-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	ODE-256	2026-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	I-942	2027-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	M-305	2027-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-001	ODE-468	2031-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-002	I-942	2027-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-002	ODE-378	2028-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210251-002	ODE-468	2031-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210251-001	ODE-256	2026-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210251-001	I-942	2027-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210251-001	M-305	2027-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210251-001	ODE-468	2031-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210251-002	I-942	2027-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210251-002	ODE-378	2028-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210251-002	ODE-468	2031-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210251-001	ODE-256	2026-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210251-001	I-942	2027-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210251-001	M-305	2027-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210251-001	ODE-468	2031-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210251-002	I-942	2027-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210251-002	ODE-378	2028-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210251-002	ODE-468	2031-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210251-001	ODE-256	2026-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210251-001	I-942	2027-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210251-001	M-305	2027-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210251-001	ODE-468	2031-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210251-002	I-942	2027-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210251-002	ODE-378	2028-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210251-002	ODE-468	2031-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210251-001	M-82	2024-02-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210251-001	ODE-256	2026-06-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210251-001	I-942	2027-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210251-001	M-305	2027-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210251-001	ODE-468	2031-02-23	`03ed91905a0d…`

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
Biktarvy	BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE	Gilead Sciences, Inc.	664cb8f0-1f65-441b-b0d9-ba3d798be309	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 210251 application number: NDA210251 ndc (product): 61958-2501 ndc (product): 61958-2505
Biktarvy	BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE	A-S Medication Solutions	0476d7eb-1024-4821-bbe7-abaacfda32a2	2024-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 210251 application number: NDA210251 ndc (product): 50090-6247

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-6247	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate	A-S Medication Solutions	NDA	Current
61958-2501	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate	Gilead Sciences, Inc.	NDA	Current
61958-2501	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate	Gilead Sciences, Inc.	NDA	Current
61958-2501	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate	Gilead Sciences, Inc.	NDA	Current
61958-2501	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate	Gilead Sciences, Inc.	NDA	Current
61958-2501	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate	Gilead Sciences, Inc.	NDA	Current
61958-2501	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate	Gilead Sciences, Inc.	NDA	Current
61958-2501	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate	Gilead Sciences, Inc.	NDA	Current
61958-2501	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate	Gilead Sciences, Inc.	NDA	Current
61958-2501	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate	Gilead Sciences, Inc.	NDA	Current
61958-2501	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate	Gilead Sciences, Inc.	NDA	Current
61958-2501	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate	Gilead Sciences, Inc.	NDA	Current
61958-2501	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate	Gilead Sciences, Inc.	NDA	Current
61958-2505	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate	Gilead Sciences, Inc.	NDA	Current
61958-2505	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate	Gilead Sciences, Inc.	NDA	Current
70518-3080	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate	REMEDYREPACK INC.	NDA	Current
70518-3080	Biktarvy	bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85994	SUPPL	2026-05-21
85989	SUPPL	2026-05-21
83009	SUPPL	2025-08-01
83003	SUPPL	2025-07-31
79960	SUPPL	2024-10-22
79957	SUPPL	2024-10-22
78262	SUPPL	2024-04-25
78243	SUPPL	2024-04-25
77624	SUPPL	2024-02-26
77615	SUPPL	2024-02-26
74229	SUPPL	2023-05-12
74228	SUPPL	2023-05-12
72393	SUPPL	2022-10-17
72353	SUPPL	2022-10-17
68979	SUPPL	2021-10-13
68954	SUPPL	2021-10-12
68617	SUPPL	2021-09-14
68593	SUPPL	2021-09-13
66748	SUPPL	2021-03-11
66542	SUPPL	2021-03-05
66459	SUPPL	2021-03-03
66361	SUPPL	2021-02-25
66344	SUPPL	2021-02-24
66209	SUPPL	2021-02-16
66140	SUPPL	2021-02-09
66117	SUPPL	2021-02-08
59591	SUPPL	2019-08-06
59578	SUPPL	2019-08-05
59138	SUPPL	2019-06-20
59122	SUPPL	2019-06-19
53053	ORIG	2018-03-19
52499	ORIG	2018-02-07
52498	ORIG	2018-02-07
62872	ORIG	1900-01-01
62871	ORIG	1900-01-01
62870	ORIG	1900-01-01