Application 204384

Type: NDA
Sponsor: JANSSEN THERAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SIRTURO	BEDAQUILINE FUMARATE	TABLET;ORAL	EQ 100MG BASE	Yes	Yes
002	SIRTURO	BEDAQUILINE FUMARATE	TABLET;ORAL	EQ 20MG BASE	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
N204384-001	SIRTURO	BEDAQUILINE FUMARATE	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2012-12-28
N204384-002	SIRTURO	BEDAQUILINE FUMARATE	EQ 20MG BASE	TABLET / ORAL		RLD	2020-05-27

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24
N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14
N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24
N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N204384-001	ODE-251	2026-08-09
N204384-001	ODE-307	2027-05-27
N204384-001	M-306	2027-06-21
N204384-001	NPP	2028-07-28
N204384-002	ODE*	2026-08-09
N204384-002	ODE-307	2027-05-27
N204384-002	M-306	2027-06-21
N204384-002	NPP	2028-07-28

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 · 82 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	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204384-002	SIRTURO	EQ 20MG BASE	TABLET / ORAL	RLD	2020-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204384-001	SIRTURO	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2012-12-28	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 164 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	N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204384-001	7498343	2026-12-01	U-1321	Drug substance, Drug product	2013-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204384-001	8546428	2029-03-19	U-1321	Drug substance, Drug product	2014-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204384-002	7498343	2026-12-01	U-1321	Drug substance, Drug product	2020-06-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204384-002	8546428	2029-03-19	U-1321	Drug substance, Drug product	2020-06-24	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 176 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	N204384-001	ODE-251	2026-08-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-001	ODE-307	2027-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-001	M-306	2027-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-001	NPP	2028-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-002	ODE*	2026-08-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-002	ODE-307	2027-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-002	M-306	2027-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204384-002	NPP	2028-07-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204384-001	ODE-251	2026-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204384-001	ODE-307	2027-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204384-001	M-306	2027-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204384-002	ODE*	2026-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204384-002	ODE-307	2027-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204384-002	M-306	2027-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204384-001	ODE-251	2026-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204384-001	ODE-307	2027-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204384-001	M-306	2027-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204384-002	ODE*	2026-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204384-002	ODE-307	2027-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204384-002	M-306	2027-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-001	ODE-251	2026-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-001	ODE-307	2027-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-001	M-306	2027-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-002	ODE*	2026-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-002	ODE-307	2027-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204384-002	M-306	2027-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204384-001	ODE-251	2026-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204384-001	ODE-307	2027-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204384-001	M-306	2027-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204384-002	ODE*	2026-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204384-002	ODE-307	2027-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204384-002	M-306	2027-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-001	ODE-251	2026-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-001	ODE-307	2027-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-001	M-306	2027-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-002	ODE-307	2027-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204384-002	M-306	2027-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204384-001	ODE-251	2026-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204384-001	ODE-307	2027-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204384-001	M-306	2027-06-21	`b8a1b40f171c…`

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
SIRTURO	BEDAQUILINE FUMARATE	Janssen Products, LP	1534c9ae-4948-4cf4-9f66-222a99db6d0e	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204384 application number: NDA204384 ndc (product): 59676-701 ndc (product): 59676-702

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59676-701	SIRTURO	Bedaquiline Fumarate	Janssen Products, LP	NDA	Current
59676-701	SIRTURO	Bedaquiline Fumarate	Janssen Products, LP	NDA	Current
59676-701	SIRTURO	Bedaquiline Fumarate	Janssen Products, LP	NDA	Current
59676-701	SIRTURO	Bedaquiline Fumarate	Janssen Products, LP	NDA	Current
59676-701	SIRTURO	Bedaquiline Fumarate	Janssen Products, LP	NDA	Current
59676-701	SIRTURO	Bedaquiline Fumarate	Janssen Products, LP	NDA	Current
59676-701	SIRTURO	Bedaquiline Fumarate	Janssen Products, LP	NDA	Current
59676-701	SIRTURO	Bedaquiline Fumarate	Janssen Products, LP	NDA	Current
59676-701	SIRTURO	Bedaquiline Fumarate	Janssen Products, LP	NDA	Current
59676-701	SIRTURO	Bedaquiline Fumarate	Janssen Products, LP	NDA	Current
59676-702	SIRTURO	Bedaquiline Fumarate	Janssen Products, LP	NDA	Current
59676-702	SIRTURO	Bedaquiline Fumarate	Janssen Products, LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82977	SUPPL	2025-07-29
82969	SUPPL	2025-07-29
82968	SUPPL	2025-07-29
78880	SUPPL	2024-06-24
78869	SUPPL	2024-06-24
75728	SUPPL	2023-10-13
75714	SUPPL	2023-10-12
68833	SUPPL	2021-10-01
68832	SUPPL	2021-10-01
68788	SUPPL	2021-09-27
63332	SUPPL	2020-05-29
63310	SUPPL	2020-05-27
61529	SUPPL	2020-01-07
61527	SUPPL	2020-01-07
61526	SUPPL	2020-01-07
61155	SUPPL	2019-12-04
61154	SUPPL	2019-12-04
61143	SUPPL	2019-12-04
59730	SUPPL	2019-08-16
59680	SUPPL	2019-08-13
59658	SUPPL	2019-08-12
19553	SUPPL	2015-12-15
10335	SUPPL	2015-12-10
19552	SUPPL	2015-05-21
32548	SUPPL	2015-05-19
10334	SUPPL	2014-10-22
19551	SUPPL	2014-10-21
40382	SUPPL	2013-08-29
32547	SUPPL	2013-08-29
24468	ORIG	2013-02-13
22955	ORIG	2013-02-13
32546	ORIG	2013-01-02
40381	ORIG	2012-12-31