Application 022187

Type: NDA
Sponsor: JANSSEN R AND D

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INTELENCE	ETRAVIRINE	TABLET;ORAL	100MG	Yes	No
002	INTELENCE	ETRAVIRINE	TABLET;ORAL	200MG	Yes	Yes
003	INTELENCE	ETRAVIRINE	TABLET;ORAL	25MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022187-001	INTELENCE	ETRAVIRINE	100MG	TABLET / ORAL	AB	RLD	2008-01-18
N022187-002	INTELENCE	ETRAVIRINE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22
N022187-003	INTELENCE	ETRAVIRINE	25MG	TABLET / ORAL		RLD	2012-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022187-001	AB
N022187-002	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 4 · 129 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
2026-09-14 22:38:34	2026-08	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022187-002	INTELENCE	200MG	TABLET / ORAL	AB	RLD, RS	2010-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022187-003	INTELENCE	25MG	TABLET / ORAL		RLD	2012-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022187-001	INTELENCE	100MG	TABLET / ORAL	AB	RLD	2008-01-18	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N022187-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022187-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022187-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022187-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022187-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022187-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022187-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022187-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022187-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022187-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022187-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022187-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022187-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022187-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022187-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022187-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022187-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022187-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022187-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022187-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022187-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022187-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022187-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022187-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022187-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022187-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022187-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022187-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022187-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022187-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022187-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022187-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022187-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022187-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022187-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022187-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022187-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022187-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022187-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022187-002	AB	1	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 207 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022187-001	7887845	2019-03-25		Drug product	2011-03-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	7887845*PED	2019-09-25		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	8003789	2019-11-01		Drug substance, Drug product	2011-09-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	6878717	2019-11-05	U-1016			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	6878717	2019-11-05	U-256			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	6878717	2019-11-05	U-2354			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	6878717	2019-11-05	U-1237			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	8003789*PED	2020-05-01		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	6878717*PED	2020-05-05		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	7037917	2020-12-13	U-1016	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	7037917	2020-12-13	U-256	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	7037917	2020-12-13	U-1237	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	7037917	2020-12-13	U-2354	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	7037917*PED	2021-06-13		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	7887845	2019-03-25		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	7887845*PED	2019-09-25		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	8003789	2019-11-01		Drug substance, Drug product	2011-09-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	6878717	2019-11-05	U-1016		2011-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	6878717	2019-11-05	U-2354		2011-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	6878717	2019-11-05	U-256		2011-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	6878717	2019-11-05	U-1237		2011-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	8003789*PED	2020-05-01		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	6878717*PED	2020-05-05		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	7037917	2020-12-13	U-2354	Drug substance, Drug product	2011-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	7037917	2020-12-13	U-256	Drug substance, Drug product	2011-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	7037917	2020-12-13	U-1016	Drug substance, Drug product	2011-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	7037917	2020-12-13	U-1237	Drug substance, Drug product	2011-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	7037917*PED	2021-06-13		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	7887845	2019-03-25		Drug product	2012-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	7887845*PED	2019-09-25		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	8003789	2019-11-01		Drug substance, Drug product	2012-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	6878717	2019-11-05	U-2354		2012-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	6878717	2019-11-05	U-256		2012-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	6878717	2019-11-05	U-1016		2012-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	6878717	2019-11-05	U-1237		2012-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	8003789*PED	2020-05-01		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	6878717*PED	2020-05-05		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	7037917	2020-12-13	U-2354	Drug substance, Drug product	2012-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	7037917	2020-12-13	U-1237	Drug substance, Drug product	2012-04-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	7037917*PED	2021-06-13		Pediatric extension		`74a2ff9319b5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022187-001	PED	2022-01-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022187-002	PED	2022-01-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022187-003	PED	2022-01-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022187-001	PED	2022-01-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022187-002	PED	2022-01-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022187-003	PED	2022-01-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022187-001	PED	2022-01-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022187-002	PED	2022-01-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022187-003	PED	2022-01-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022187-001	NPP	2021-07-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-001	PED	2022-01-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	NPP	2021-07-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-002	PED	2022-01-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	NPP	2021-07-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022187-003	PED	2022-01-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022187-001	PED	2022-01-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022187-002	PED	2022-01-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022187-003	PED	2022-01-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022187-001	NPP	2021-07-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022187-001	PED	2022-01-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022187-002	NPP	2021-07-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022187-002	PED	2022-01-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022187-003	NPP	2021-07-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022187-003	PED	2022-01-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022187-001	NPP	2021-07-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022187-001	PED	2022-01-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022187-002	NPP	2021-07-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022187-002	PED	2022-01-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022187-003	NPP	2021-07-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022187-003	PED	2022-01-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022187-001	NPP	2021-07-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022187-001	PED	2022-01-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022187-002	NPP	2021-07-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022187-002	PED	2022-01-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022187-003	NPP	2021-07-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022187-003	PED	2022-01-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022187-001	NPP	2021-07-16	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022187-001	PED	2022-01-16	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022187-002	NPP	2021-07-16	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022187-002	PED	2022-01-16	`8869cabd3fbd…`

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
Etravirine	ETRAVIRINE	Patriot Pharmaceuticals	50ca19cb-0f43-4d7b-8c9e-8b3aaded0546	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022187 application number: NDA022187
Intelence	ETRAVIRINE	Janssen Products LP	6a9cbc29-9f15-4b24-8d86-206b82887f3d	2023-08-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022187 application number: NDA022187 ndc (product): 59676-570 ndc (product): 59676-572 ndc (product): 59676-571

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53808-0787	Intelence	Etravirine	State of Florida DOH Central Pharmacy	NDA	Current
59676-570	Intelence	etravirine	Janssen Products LP	NDA	Current
59676-570	Intelence	etravirine	Janssen Products LP	NDA	Current
59676-570	Intelence	etravirine	Janssen Products LP	NDA	Current
59676-570	Intelence	etravirine	Janssen Products LP	NDA	Current
59676-570	Intelence	etravirine	Janssen Products LP	NDA	Current
59676-571	Intelence	etravirine	Janssen Products LP	NDA	Current
59676-571	Intelence	etravirine	Janssen Products LP	NDA	Current
59676-571	Intelence	etravirine	Janssen Products LP	NDA	Current
59676-571	Intelence	etravirine	Janssen Products LP	NDA	Current
59676-571	Intelence	etravirine	Janssen Products LP	NDA	Current
59676-572	Intelence	etravirine	Janssen Products LP	NDA	Current
59676-572	Intelence	etravirine	Janssen Products LP	NDA	Current
59676-572	Intelence	etravirine	Janssen Products LP	NDA	Current
59676-572	Intelence	etravirine	Janssen Products LP	NDA	Current
59676-572	Intelence	etravirine	Janssen Products LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63916	ORIG	2020-07-15
59557	SUPPL	2019-08-02
59312	SUPPL	2019-07-11
56460	SUPPL	2018-11-15
56382	SUPPL	2018-11-08
54952	SUPPL	2018-07-23
54910	SUPPL	2018-07-18
38358	SUPPL	2014-08-22
7015	SUPPL	2014-08-21
29380	SUPPL	2013-03-01
29379	SUPPL	2013-03-01
17059	SUPPL	2013-03-01
17058	SUPPL	2013-03-01
17057	SUPPL	2013-03-01
7014	SUPPL	2013-03-01
29378	SUPPL	2012-08-15
17056	SUPPL	2012-08-15
7013	SUPPL	2012-03-28
17055	SUPPL	2012-03-26
38357	SUPPL	2011-10-12
29377	SUPPL	2011-10-12
29376	SUPPL	2010-12-28
38356	SUPPL	2010-12-26
17054	SUPPL	2010-12-22
7012	SUPPL	2010-12-22
38355	SUPPL	2010-03-03
29375	SUPPL	2010-03-03
38353	SUPPL	2009-12-02
29374	SUPPL	2009-11-10
38354	SUPPL	2009-10-06
44697	ORIG	2008-07-22
42441	ORIG	2008-03-17
38352	ORIG	2008-01-23
29373	ORIG	2008-01-23
63915	ORIG	1900-01-01
63914	ORIG	1900-01-01
63913	ORIG	1900-01-01
63912	ORIG	1900-01-01
62997	SUPPL	1900-01-01
62996	SUPPL	1900-01-01
53271	ORIG	1900-01-01
53270	ORIG	1900-01-01