Application 213004

Type: NDA
Sponsor: REDHILL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TALICIA	AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN	CAPSULE, DELAYED RELEASE;ORAL	250MG;EQ 10MG BASE;12.5MG	Yes	Yes

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

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
N213004-001	TALICIA	AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL		RLD, RS	2019-11-01

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213004-001	10238606	2034-02-12		Drug product	2019-11-25
N213004-001	11135172	2034-02-12	U-2660	Drug product	2021-10-07
N213004-001	11931463	2034-02-12	U-3866	Drug product	2024-04-04
N213004-001	9050263	2034-02-12	U-2660	Drug product	2019-11-25
N213004-001	9498445	2034-02-12	U-2660	Drug product	2019-11-25
N213004-001	9603806	2034-02-12	U-2660	Drug product	2019-11-25
N213004-001	11878011	2042-05-27	U-3816		2024-02-21

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213004-001	NP	2022-11-01
N213004-001	GAIN	2027-11-01

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.

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	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213004-001	TALICIA	250MG;EQ 10MG BASE;12.5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2019-11-01	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 230 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	N213004-001	10238606	2034-02-12		Drug product	2019-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213004-001	11135172	2034-02-12	U-2660	Drug product	2021-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213004-001	11931463	2034-02-12	U-3866	Drug product	2024-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213004-001	9050263	2034-02-12	U-2660	Drug product	2019-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213004-001	9498445	2034-02-12	U-2660	Drug product	2019-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213004-001	9603806	2034-02-12	U-2660	Drug product	2019-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213004-001	11878011	2042-05-27	U-3816		2024-02-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213004-001	10238606	2034-02-12		Drug product	2019-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213004-001	11135172	2034-02-12	U-2660	Drug product	2021-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213004-001	11931463	2034-02-12	U-3866	Drug product	2024-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213004-001	9050263	2034-02-12	U-2660	Drug product	2019-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213004-001	9498445	2034-02-12	U-2660	Drug product	2019-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213004-001	9603806	2034-02-12	U-2660	Drug product	2019-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213004-001	11878011	2042-05-27	U-3816		2024-02-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213004-001	10238606	2034-02-12		Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213004-001	11135172	2034-02-12	U-2660	Drug product	2021-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213004-001	11931463	2034-02-12	U-3866	Drug product	2024-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213004-001	9050263	2034-02-12	U-2660	Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213004-001	9498445	2034-02-12	U-2660	Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213004-001	9603806	2034-02-12	U-2660	Drug product	2019-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213004-001	11878011	2042-05-27	U-3816		2024-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213004-001	10238606	2034-02-12		Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213004-001	11135172	2034-02-12	U-2660	Drug product	2021-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213004-001	11931463	2034-02-12	U-3866	Drug product	2024-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213004-001	9050263	2034-02-12	U-2660	Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213004-001	9498445	2034-02-12	U-2660	Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213004-001	9603806	2034-02-12	U-2660	Drug product	2019-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213004-001	11878011	2042-05-27	U-3816		2024-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213004-001	10238606	2034-02-12		Drug product	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213004-001	11135172	2034-02-12	U-2660	Drug product	2021-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213004-001	11931463	2034-02-12	U-3866	Drug product	2024-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213004-001	9050263	2034-02-12	U-2660	Drug product	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213004-001	9498445	2034-02-12	U-2660	Drug product	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213004-001	9603806	2034-02-12	U-2660	Drug product	2019-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213004-001	11878011	2042-05-27	U-3816		2024-02-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213004-001	10238606	2034-02-12		Drug product	2019-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213004-001	11135172	2034-02-12	U-2660	Drug product	2021-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213004-001	11931463	2034-02-12	U-3866	Drug product	2024-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213004-001	9050263	2034-02-12	U-2660	Drug product	2019-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213004-001	9498445	2034-02-12	U-2660	Drug product	2019-11-25	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 42 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	N213004-001	NP	2022-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213004-001	GAIN	2027-11-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213004-001	NP	2022-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213004-001	GAIN	2027-11-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213004-001	NP	2022-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213004-001	GAIN	2027-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213004-001	NP	2022-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213004-001	GAIN	2027-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213004-001	NP	2022-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213004-001	GAIN	2027-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213004-001	NP	2022-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213004-001	GAIN	2027-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213004-001	NP	2022-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213004-001	GAIN	2027-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213004-001	NP	2022-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213004-001	GAIN	2027-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213004-001	NP	2022-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213004-001	GAIN	2027-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213004-001	NP	2022-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213004-001	GAIN	2027-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213004-001	NP	2022-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213004-001	GAIN	2027-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213004-001	NP	2022-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213004-001	GAIN	2027-11-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213004-001	NP	2022-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213004-001	GAIN	2027-11-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213004-001	NP	2022-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213004-001	GAIN	2027-11-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213004-001	NP	2022-11-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213004-001	GAIN	2027-11-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213004-001	NP	2022-11-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213004-001	GAIN	2027-11-01	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213004-001	NP	2022-11-01	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213004-001	GAIN	2027-11-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213004-001	NP	2022-11-01	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N213004-001	GAIN	2027-11-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213004-001	NP	2022-11-01	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N213004-001	GAIN	2027-11-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213004-001	NP	2022-11-01	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213004-001	GAIN	2027-11-01	`a72a2bbeb626…`

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
Talicia	OMEPRAZOLE MAGNESIUM, AMOXICILLIN AND RIFABUTIN	RedHill Biopharma Ltd	68c4e9dc-dbcf-4151-b6f7-5e4b9922b76f	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213004 application number: NDA213004 ndc (product): 57841-1150

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57841-1150	Talicia	omeprazole magnesium, amoxicillin and rifabutin	RedHill Biopharma Ltd	NDA	Current
57841-1150	Talicia	omeprazole magnesium, amoxicillin and rifabutin	RedHill Biopharma Ltd	NDA	Current
57841-1150	Talicia	omeprazole magnesium, amoxicillin and rifabutin	RedHill Biopharma Ltd	NDA	Current
57841-1150	Talicia	omeprazole magnesium, amoxicillin and rifabutin	RedHill Biopharma Ltd	NDA	Current
57841-1150	Talicia	omeprazole magnesium, amoxicillin and rifabutin	RedHill Biopharma Ltd	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78381	SUPPL	2024-05-03
78358	SUPPL	2024-05-02
75444	SUPPL	2023-09-13
75388	SUPPL	2023-09-11
74832	SUPPL	2023-07-20
74787	SUPPL	2023-07-19
70501	SUPPL	2022-03-14
70434	SUPPL	2022-03-07
68879	SUPPL	2021-10-05
68853	SUPPL	2021-10-01
65439	SUPPL	2020-12-01
65365	SUPPL	2020-11-30
62520	ORIG	2020-04-09
60788	ORIG	2019-11-07
60780	ORIG	2019-11-05