Application 208464

Type: NDA
Sponsor: GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VEMLIDY	TENOFOVIR ALAFENAMIDE FUMARATE	TABLET;ORAL	EQ 25MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208464-001	VEMLIDY	TENOFOVIR ALAFENAMIDE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N208464-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208464-001	8754065	2032-08-15	U-1275	Drug substance, Drug product	2016-11-28
N208464-001	8754065	2032-08-15	U-3880	Drug substance, Drug product	2016-11-28
N208464-001	8754065	2032-08-15	U-999	Drug substance, Drug product	2016-11-28
N208464-001	9296769	2032-08-15	U-1275	Drug substance, Drug product	2016-11-28
N208464-001	9296769	2032-08-15	U-3880	Drug substance, Drug product	2016-11-28
N208464-001	9296769	2032-08-15	U-999	Drug substance, Drug product	2016-11-28
N208464-001	8754065*PED	2033-02-15		Pediatric extension
N208464-001	9296769*PED	2033-02-15		Pediatric extension

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208464-001	NPP	2027-03-27

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL	AB	RLD, RS	2016-11-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208464-001	VEMLIDY	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2016-11-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208464-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208464-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208464-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208464-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208464-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208464-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208464-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208464-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208464-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208464-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208464-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208464-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208464-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208464-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208464-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208464-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208464-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208464-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208464-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208464-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208464-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 314 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	N208464-001	8754065	2032-08-15	U-999	Drug substance, Drug product	2016-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208464-001	8754065	2032-08-15	U-1275	Drug substance, Drug product	2016-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208464-001	8754065	2032-08-15	U-3880	Drug substance, Drug product	2016-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208464-001	9296769	2032-08-15	U-1275	Drug substance, Drug product	2016-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208464-001	9296769	2032-08-15	U-3880	Drug substance, Drug product	2016-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208464-001	9296769	2032-08-15	U-999	Drug substance, Drug product	2016-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208464-001	8754065*PED	2033-02-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208464-001	9296769*PED	2033-02-15		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	7390791	2025-01-07		Drug substance, Drug product	2016-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	7390791*PED	2025-07-07		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	8754065	2032-08-15	U-999	Drug substance, Drug product	2016-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	8754065	2032-08-15	U-1275	Drug substance, Drug product	2016-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	8754065	2032-08-15	U-3880	Drug substance, Drug product	2016-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	9296769	2032-08-15	U-1275	Drug substance, Drug product	2016-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	9296769	2032-08-15	U-3880	Drug substance, Drug product	2016-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	9296769	2032-08-15	U-999	Drug substance, Drug product	2016-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	8754065*PED	2033-02-15		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	9296769*PED	2033-02-15		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208464-001	7390791	2025-01-07		Drug substance, Drug product	2016-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208464-001	7390791*PED	2025-07-07		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208464-001	8754065	2032-08-15	U-999	Drug substance, Drug product	2016-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208464-001	8754065	2032-08-15	U-1275	Drug substance, Drug product	2016-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208464-001	8754065	2032-08-15	U-3880	Drug substance, Drug product	2016-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208464-001	9296769	2032-08-15	U-1275	Drug substance, Drug product	2016-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208464-001	9296769	2032-08-15	U-3880	Drug substance, Drug product	2016-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208464-001	9296769	2032-08-15	U-999	Drug substance, Drug product	2016-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208464-001	8754065*PED	2033-02-15		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208464-001	9296769*PED	2033-02-15		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	7390791	2025-01-07		Drug substance, Drug product	2016-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	7390791*PED	2025-07-07		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	8754065	2032-08-15	U-999	Drug substance, Drug product	2016-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	8754065	2032-08-15	U-1275	Drug substance, Drug product	2016-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	8754065	2032-08-15	U-3880	Drug substance, Drug product	2016-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	9296769	2032-08-15	U-1275	Drug substance, Drug product	2016-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	9296769	2032-08-15	U-3880	Drug substance, Drug product	2016-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	9296769	2032-08-15	U-999	Drug substance, Drug product	2016-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	8754065*PED	2033-02-15		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	9296769*PED	2033-02-15		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208464-001	7390791	2025-01-07		Drug substance, Drug product	2016-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208464-001	7390791*PED	2025-07-07		Pediatric extension		`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 73 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208464-001	NPP	2025-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208464-001	NPP	2025-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208464-001	NPP	2025-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208464-001	NPP	2025-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208464-001	NPP	2025-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208464-001	NPP	2025-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208464-001	NPP	2025-10-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208464-001	NPP	2025-10-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208464-001	NPP	2025-10-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208464-001	NPP	2025-10-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208464-001	NPP	2025-10-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208464-001	NPP	2025-10-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208464-001	NPP	2025-10-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208464-001	M-255	2023-02-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208464-001	M-266	2023-08-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208464-001	M-255	2023-02-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208464-001	M-266	2023-08-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208464-001	M-255	2023-02-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208464-001	M-266	2023-08-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208464-001	NP	2019-11-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208464-001	NCE	2020-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208464-001	M-255	2023-02-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208464-001	M-266	2023-08-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208464-001	M-255	2023-02-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208464-001	M-266	2023-08-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208464-001	M-255	2023-02-04	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208464-001	M-266	2023-08-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208464-001	M-255	2023-02-04	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208464-001	M-266	2023-08-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208464-001	NCE	2020-11-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208464-001	M-255	2023-02-04	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208464-001	M-266	2023-08-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208464-001	NCE	2020-11-05	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208464-001	M-255	2023-02-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208464-001	NP	2019-11-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208464-001	NCE	2020-11-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208464-001	NP	2019-11-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208464-001	NCE	2020-11-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208464-001	NP	2019-11-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208464-001	NCE	2020-11-05	`ea99ee380514…`

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
VEMLIDY	TENOFOVIR ALAFENAMIDE	Gilead Sciences, Inc.	72e6b33c-0351-4070-9172-eeaa186c01d2	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 208464 application number: NDA208464 ndc (product): 61958-2301

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61958-2301	VEMLIDY	tenofovir alafenamide	Gilead Sciences, Inc.	NDA	Current
61958-2301	VEMLIDY	tenofovir alafenamide	Gilead Sciences, Inc.	NDA	Current
61958-2301	VEMLIDY	tenofovir alafenamide	Gilead Sciences, Inc.	NDA	Current
61958-2301	VEMLIDY	tenofovir alafenamide	Gilead Sciences, Inc.	NDA	Current
61958-2301	VEMLIDY	tenofovir alafenamide	Gilead Sciences, Inc.	NDA	Current
61958-2301	VEMLIDY	tenofovir alafenamide	Gilead Sciences, Inc.	NDA	Current
61958-2301	VEMLIDY	tenofovir alafenamide	Gilead Sciences, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78009	SUPPL	2024-04-01
78008	SUPPL	2024-04-01
78002	SUPPL	2024-03-28
78001	SUPPL	2024-03-28
73570	SUPPL	2023-02-21
72423	SUPPL	2022-10-19
72405	SUPPL	2022-10-18
68633	SUPPL	2021-09-17
68629	SUPPL	2021-09-17
66679	SUPPL	2021-03-09
66512	SUPPL	2021-03-05
64314	SUPPL	2020-08-19
64312	SUPPL	2020-08-19
64309	SUPPL	2020-08-19
64308	SUPPL	2020-08-19
61849	SUPPL	2020-02-10
61779	SUPPL	2020-02-05
57589	SUPPL	2019-02-13
57436	SUPPL	2019-02-05
54780	SUPPL	2018-07-06
50486	ORIG	2017-11-27
47983	SUPPL	2017-04-12
47911	SUPPL	2017-04-10
45896	ORIG	2016-11-15
45888	ORIG	2016-11-14