Application 021752

Type: NDA
Sponsor: GILEAD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRUVADA	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	200MG;300MG	Yes	Yes
002	TRUVADA	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	100MG;150MG	Yes	No
003	TRUVADA	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	133MG;200MG	Yes	No
004	TRUVADA	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	167MG;250MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021752-001	TRUVADA	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02
N021752-002	TRUVADA	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10
N021752-003	TRUVADA	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10
N021752-004	TRUVADA	EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021752-001	AB
N021752-002	AB
N021752-003	AB
N021752-004	AB

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 5 · 164 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	N021752-001	TRUVADA	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021752-002	TRUVADA	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021752-003	TRUVADA	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021752-004	TRUVADA	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021752-001	TRUVADA	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021752-002	TRUVADA	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021752-003	TRUVADA	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021752-004	TRUVADA	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021752-001	TRUVADA	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021752-002	TRUVADA	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021752-003	TRUVADA	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021752-004	TRUVADA	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021752-001	TRUVADA	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021752-002	TRUVADA	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021752-003	TRUVADA	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021752-004	TRUVADA	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021752-001	TRUVADA	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021752-002	TRUVADA	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021752-003	TRUVADA	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021752-004	TRUVADA	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-001	TRUVADA	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-002	TRUVADA	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-003	TRUVADA	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-004	TRUVADA	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-001	TRUVADA	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-002	TRUVADA	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-003	TRUVADA	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-004	TRUVADA	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-001	TRUVADA	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-002	TRUVADA	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-003	TRUVADA	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-004	TRUVADA	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-001	TRUVADA	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-002	TRUVADA	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-003	TRUVADA	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-004	TRUVADA	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021752-001	TRUVADA	200MG;300MG	TABLET / ORAL	AB	RLD, RS	2004-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-002	TRUVADA	100MG;150MG	TABLET / ORAL	AB	RLD	2016-03-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-003	TRUVADA	133MG;200MG	TABLET / ORAL	AB	RLD	2016-03-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-004	TRUVADA	167MG;250MG	TABLET / ORAL	AB	RLD	2016-03-10	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 146 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021752-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021752-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021752-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021752-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021752-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021752-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021752-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021752-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021752-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021752-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021752-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021752-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021752-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021752-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021752-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021752-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021752-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021752-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021752-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021752-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021752-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-004	AB	1	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 390 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-001	8592397	2024-01-13	U-248	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-001	8592397	2024-01-13	U-541	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-001	8592397	2024-01-13	U-1170	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-001	8716264	2024-01-13	U-257	Drug product	2014-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-001	9457036	2024-01-13	U-257	Drug product	2016-11-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021752-001	9744181	2024-01-13	U-257	Drug product	2017-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-001	8592397	2024-01-13	U-248	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-001	8592397	2024-01-13	U-541	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-001	8592397	2024-01-13	U-1170	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-001	8716264	2024-01-13	U-257	Drug product	2014-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-001	9457036	2024-01-13	U-257	Drug product	2016-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021752-001	9744181	2024-01-13	U-257	Drug product	2017-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-001	8592397	2024-01-13	U-248	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-001	8592397	2024-01-13	U-541	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-001	8592397	2024-01-13	U-1170	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-001	8716264	2024-01-13	U-257	Drug product	2014-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-001	9457036	2024-01-13	U-257	Drug product	2016-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021752-001	9744181	2024-01-13	U-257	Drug product	2017-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-001	8592397	2024-01-13	U-248	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-001	8592397	2024-01-13	U-541	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-001	8592397	2024-01-13	U-1170	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-001	8716264	2024-01-13	U-257	Drug product	2014-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-001	9457036	2024-01-13	U-257	Drug product	2016-11-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021752-001	9744181	2024-01-13	U-257	Drug product	2017-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021752-001	8592397	2024-01-13	U-248	Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-001	8592397	2024-01-13	U-541	Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-001	8592397	2024-01-13	U-1170	Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-001	8716264	2024-01-13	U-257	Drug product	2014-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-001	9457036	2024-01-13	U-257	Drug product	2016-11-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021752-001	9744181	2024-01-13	U-257	Drug product	2017-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021752-001	8592397	2024-01-13	U-248	Drug product		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021752-001	8592397	2024-01-13	U-541	Drug product		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021752-001	8592397	2024-01-13	U-1170	Drug product		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021752-001	8716264	2024-01-13	U-257	Drug product	2014-05-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021752-001	9457036	2024-01-13	U-257	Drug product	2016-11-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021752-001	9744181	2024-01-13	U-257	Drug product	2017-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021752-001	8592397	2024-01-13	U-248	Drug product		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021752-001	8592397	2024-01-13	U-541	Drug product		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021752-001	8592397	2024-01-13	U-1170	Drug product		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021752-001	8716264	2024-01-13	U-257	Drug product	2014-05-30	`301d65b070ca…`

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
Truvada	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Gilead Sciences, Inc	54e82b13-a037-49ed-b4b3-030b37c0ecdd	2025-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021752 application number: NDA021752 ndc (product): 61958-0705 ndc (product): 61958-0701 ndc (product): 61958-0704 ndc (product): 61958-0703
Truvada	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	NuCare Pharmaceuticals,Inc.	46e06df0-654d-43cc-e054-00144ff8d46c	2024-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021752 application number: NDA021752 ndc (product): 68071-2112

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
35356-070	Truvada	emtricitabine and tenofovir disoproxil fumarate	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
50090-0870	Truvada	emtricitabine and tenofovir disoproxil fumarate	A-S Medication Solutions	NDA	Current
50090-0870	Truvada	emtricitabine and tenofovir disoproxil fumarate	A-S Medication Solutions	NDA	Current
50090-0870	Truvada	emtricitabine and tenofovir disoproxil fumarate	A-S Medication Solutions	NDA	Current
50090-0870	Truvada	emtricitabine and tenofovir disoproxil fumarate	A-S Medication Solutions	NDA	Current
52959-969	Truvada	emtricitabine and tenofovir disoproxil fumarate	H.J. Harkins Company, Inc.	NDA	Current
53808-0805	Truvada	emtricitabine and tenofovir disoproxil fumarate	State of Florida DOH Central Pharmacy	NDA	Current
61919-669	TRUVADA	emtricitabine and tenofovir disoproxil fumarate	DIRECT RX	NDA	Current
61919-669	TRUVADA	emtricitabine and tenofovir disoproxil fumarate	DIRECT RX	NDA	Current
61958-0701	Truvada	emtricitabine and tenofovir disoproxil fumarate	Gilead Sciences, Inc	NDA	Current
61958-0701	Truvada	emtricitabine and tenofovir disoproxil fumarate	Gilead Sciences, Inc	NDA	Current
61958-0701	Truvada	emtricitabine and tenofovir disoproxil fumarate	Gilead Sciences, Inc	NDA	Current
61958-0701	Truvada	emtricitabine and tenofovir disoproxil fumarate	Gilead Sciences, Inc	NDA	Current
61958-0701	Truvada	emtricitabine and tenofovir disoproxil fumarate	Gilead Sciences, Inc	NDA	Current
61958-0703	Truvada	emtricitabine and tenofovir disoproxil fumarate	Gilead Sciences, Inc	NDA	Current
61958-0703	Truvada	emtricitabine and tenofovir disoproxil fumarate	Gilead Sciences, Inc	NDA	Current
61958-0703	Truvada	emtricitabine and tenofovir disoproxil fumarate	Gilead Sciences, Inc	NDA	Current
61958-0703	Truvada	emtricitabine and tenofovir disoproxil fumarate	Gilead Sciences, Inc	NDA	Current
61958-0703	Truvada	emtricitabine and tenofovir disoproxil fumarate	Gilead Sciences, Inc	NDA	Current
61958-0704	Truvada	emtricitabine and tenofovir disoproxil fumarate	Gilead Sciences, Inc	NDA	Current
61958-0704	Truvada	emtricitabine and tenofovir disoproxil fumarate	Gilead Sciences, Inc	NDA	Current
61958-0704	Truvada	emtricitabine and tenofovir disoproxil fumarate	Gilead Sciences, Inc	NDA	Current
61958-0704	Truvada	emtricitabine and tenofovir disoproxil fumarate	Gilead Sciences, Inc	NDA	Current
61958-0704	Truvada	emtricitabine and tenofovir disoproxil fumarate	Gilead Sciences, Inc	NDA	Current
61958-0705	Truvada	emtricitabine and tenofovir disoproxil fumarate	Gilead Sciences, Inc	NDA	Current
61958-0705	Truvada	emtricitabine and tenofovir disoproxil fumarate	Gilead Sciences, Inc	NDA	Current
61958-0705	Truvada	emtricitabine and tenofovir disoproxil fumarate	Gilead Sciences, Inc	NDA	Current
61958-0705	Truvada	emtricitabine and tenofovir disoproxil fumarate	Gilead Sciences, Inc	NDA	Current
61958-0705	Truvada	emtricitabine and tenofovir disoproxil fumarate	Gilead Sciences, Inc	NDA	Current
63629-7581	Truvada	emtricitabine and tenofovir disoproxil fumarate	Bryant Ranch Prepack	NDA	Current
63629-7581	Truvada	emtricitabine and tenofovir disoproxil fumarate	Bryant Ranch Prepack	NDA	Current
63629-7581	Truvada	emtricitabine and tenofovir disoproxil fumarate	Bryant Ranch Prepack	NDA	Current
67296-1237	Truvada	Truvada	RedPharm Drug, Inc.	NDA	Current
67296-1237	Truvada	Truvada	RedPharm Drug, Inc.	NDA	Current
67296-1237	Truvada	Truvada	RedPharm Drug, Inc.	NDA	Current
68071-2112	Truvada	emtricitabine and tenofovir disoproxil fumarate	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-2112	Truvada	emtricitabine and tenofovir disoproxil fumarate	NuCare Pharmaceuticals,Inc.	NDA	Current
69189-0701	Truvada	emtricitabine and tenofovir disoproxil fumarate	Avera McKennan Hospital	NDA	Current
70518-0097	Truvada	emtricitabine and tenofovir disoproxil fumarate	REMEDYREPACK INC.	NDA	Current
70518-0097	Truvada	emtricitabine and tenofovir disoproxil fumarate	REMEDYREPACK INC.	NDA	Current
70518-0097	Truvada	emtricitabine and tenofovir disoproxil fumarate	REMEDYREPACK INC.	NDA	Current
70518-0097	Truvada	emtricitabine and tenofovir disoproxil fumarate	REMEDYREPACK INC.	NDA	Current
70518-0097	Truvada	emtricitabine and tenofovir disoproxil fumarate	REMEDYREPACK INC.	NDA	Current
70518-0097	Truvada	emtricitabine and tenofovir disoproxil fumarate	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80160	SUPPL	2024-11-05
78305	SUPPL	2024-05-03
78314	SUPPL	2024-04-30
78313	SUPPL	2024-04-30
75720	SUPPL	2023-10-13
75708	SUPPL	2023-10-12
75707	SUPPL	2023-10-12
63684	SUPPL	2020-06-24
63683	SUPPL	2020-06-24
63682	SUPPL	2020-06-24
59204	SUPPL	2019-07-02
54234	SUPPL	2018-05-17
54217	SUPPL	2018-05-16
50051	APPL	2017-10-12
48690	SUPPL	2017-06-09
48091	SUPPL	2017-04-24
48090	SUPPL	2017-04-24
48089	SUPPL	2017-04-24
37586	SUPPL	2016-03-15
28525	SUPPL	2016-03-14
6124	SUPPL	2016-02-29
37587	SUPPL	2016-02-26
6123	SUPPL	2014-06-19
37585	SUPPL	2013-12-17
28524	SUPPL	2013-12-17
37584	SUPPL	2013-10-25
6122	SUPPL	2013-10-25
28523	SUPPL	2013-06-19
16311	SUPPL	2013-06-17
44648	SUPPL	2012-08-02
21805	SUPPL	2012-08-02
37583	SUPPL	2012-07-18
6121	SUPPL	2012-07-17
16310	SUPPL	2012-07-16
6120	SUPPL	2012-07-16
28522	SUPPL	2011-07-12
16309	SUPPL	2011-07-12
6119	SUPPL	2010-01-21
37582	SUPPL	2009-11-19
16308	SUPPL	2008-11-07
6118	SUPPL	2008-11-07
42298	SUPPL	2008-07-30
28521	SUPPL	2008-05-21
16307	SUPPL	2007-05-29
6117	SUPPL	2007-05-29
28519	SUPPL	2006-03-23
16306	SUPPL	2006-03-10
21804	ORIG	2006-01-31
28520	SUPPL	2005-10-11
37581	SUPPL	2005-10-10
37580	SUPPL	2005-03-30
28518	SUPPL	2005-03-30
16305	ORIG	2004-08-05
6116	ORIG	2004-08-05
52470	ORIG	1900-01-01
52469	ORIG	1900-01-01