Application 211109

Type: NDA
Sponsor: TETRAPHASE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XERAVA	ERAVACYCLINE DIHYDROCHLORIDE	POWDER;INTRAVENOUS	EQ 50MG BASE/VIAL	Yes	Yes
002	XERAVA	ERAVACYCLINE DIHYDROCHLORIDE	POWDER;INTRAVENOUS	EQ 100MG BASE/VIAL	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N211109-001	XERAVA	ERAVACYCLINE DIHYDROCHLORIDE	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2018-08-27
N211109-002	XERAVA	ERAVACYCLINE DIHYDROCHLORIDE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2020-06-03

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
N211109-001	8796245	2029-08-07	U-2380		2018-09-13
N211109-001	8906887	2032-08-27		Drug product	2018-09-13
N211109-001	10961190	2037-10-19		Drug substance	2022-01-13
N211109-001	11578044	2037-10-19		Drug substance	2023-03-17
N211109-002	8796245	2029-08-07	U-2380		2021-12-15
N211109-002	8906887	2032-08-27		Drug product	2021-12-15
N211109-002	10961190	2037-10-19		Drug substance	2022-01-13
N211109-002	11578044	2037-10-19		Drug substance	2023-03-17

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211109-001	NCE	2023-08-27
N211109-001	GAIN	2028-08-27
N211109-002	NCE	2023-08-27
N211109-002	GAIN	2028-08-27

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N211109-001	XERAVA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-08-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211109-002	XERAVA	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-06-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N211109-001	XERAVA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211109-002	XERAVA	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-06-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211109-001	XERAVA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211109-002	XERAVA	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211109-001	XERAVA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211109-002	XERAVA	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211109-001	XERAVA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211109-002	XERAVA	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211109-001	XERAVA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211109-002	XERAVA	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211109-001	XERAVA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211109-002	XERAVA	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211109-001	XERAVA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211109-002	XERAVA	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211109-001	XERAVA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211109-002	XERAVA	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211109-001	XERAVA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211109-002	XERAVA	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211109-001	XERAVA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211109-002	XERAVA	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211109-001	XERAVA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211109-002	XERAVA	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211109-001	XERAVA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211109-002	XERAVA	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211109-001	XERAVA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211109-002	XERAVA	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211109-001	XERAVA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211109-002	XERAVA	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211109-001	XERAVA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211109-002	XERAVA	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211109-001	XERAVA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-08-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211109-002	XERAVA	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211109-001	XERAVA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-08-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211109-002	XERAVA	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211109-001	XERAVA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-08-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211109-002	XERAVA	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211109-001	XERAVA	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2018-08-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211109-002	XERAVA	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2020-06-03	`4b0b4de00fa7…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 280 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N211109-001	8796245	2029-08-07	U-2380		2018-09-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211109-001	8906887	2032-08-27		Drug product	2018-09-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211109-001	10961190	2037-10-19		Drug substance	2022-01-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211109-001	11578044	2037-10-19		Drug substance	2023-03-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211109-002	8796245	2029-08-07	U-2380		2021-12-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211109-002	8906887	2032-08-27		Drug product	2021-12-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211109-002	10961190	2037-10-19		Drug substance	2022-01-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211109-002	11578044	2037-10-19		Drug substance	2023-03-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N211109-001	8796245	2029-08-07	U-2380		2018-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211109-001	8906887	2032-08-27		Drug product	2018-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211109-001	10961190	2037-10-19		Drug substance	2022-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211109-001	11578044	2037-10-19		Drug substance	2023-03-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211109-002	8796245	2029-08-07	U-2380		2021-12-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211109-002	8906887	2032-08-27		Drug product	2021-12-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211109-002	10961190	2037-10-19		Drug substance	2022-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211109-002	11578044	2037-10-19		Drug substance	2023-03-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211109-001	8796245	2029-08-07	U-2380		2018-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211109-001	8906887	2032-08-27		Drug product	2018-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211109-001	10961190	2037-10-19		Drug substance	2022-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211109-001	11578044	2037-10-19		Drug substance	2023-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211109-002	8796245	2029-08-07	U-2380		2021-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211109-002	8906887	2032-08-27		Drug product	2021-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211109-002	10961190	2037-10-19		Drug substance	2022-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211109-002	11578044	2037-10-19		Drug substance	2023-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211109-001	8796245	2029-08-07	U-2380		2018-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211109-001	8906887	2030-12-28		Drug product	2018-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211109-001	10961190	2037-10-19		Drug substance	2022-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211109-001	11578044	2037-10-19		Drug substance	2023-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211109-002	8796245	2029-08-07	U-2380		2021-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211109-002	8906887	2030-12-28		Drug product	2021-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211109-002	10961190	2037-10-19		Drug substance	2022-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211109-002	11578044	2037-10-19		Drug substance	2023-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211109-001	8796245	2029-08-07	U-2380		2018-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211109-001	8906887	2030-12-28		Drug product	2018-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211109-001	10961190	2037-10-19		Drug substance	2022-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211109-001	11578044	2037-10-19		Drug substance	2023-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211109-002	8796245	2029-08-07	U-2380		2021-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211109-002	8906887	2030-12-28		Drug product	2021-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211109-002	10961190	2037-10-19		Drug substance	2022-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211109-002	11578044	2037-10-19		Drug substance	2023-03-17	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 4 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211109-001	NCE	2023-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211109-001	GAIN	2028-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211109-002	NCE	2023-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211109-002	GAIN	2028-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211109-001	NCE	2023-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211109-001	GAIN	2028-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211109-002	NCE	2023-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211109-002	GAIN	2028-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211109-001	NCE	2023-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211109-001	GAIN	2028-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211109-002	NCE	2023-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211109-002	GAIN	2028-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211109-001	NCE	2023-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211109-001	GAIN	2028-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211109-002	NCE	2023-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211109-002	GAIN	2028-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211109-001	NCE	2023-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211109-001	GAIN	2028-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211109-002	NCE	2023-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211109-002	GAIN	2028-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211109-001	NCE	2023-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211109-001	GAIN	2028-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211109-002	NCE	2023-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211109-002	GAIN	2028-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211109-001	NCE	2023-08-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211109-001	GAIN	2028-08-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211109-002	NCE	2023-08-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211109-002	GAIN	2028-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211109-001	NCE	2023-08-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211109-001	GAIN	2028-08-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211109-002	NCE	2023-08-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211109-002	GAIN	2028-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211109-001	NCE	2023-08-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211109-001	GAIN	2028-08-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211109-002	NCE	2023-08-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211109-002	GAIN	2028-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211109-001	NCE	2023-08-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211109-001	GAIN	2028-08-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211109-002	NCE	2023-08-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211109-002	GAIN	2028-08-27	`4b0b4de00fa7…`

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
Xerava	ERAVACYCLINE	Tetraphase Pharmaceuticals, Inc.	a4b188d4-f467-470c-ad7b-25ffbdd8862a	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211109 application number: NDA211109 ndc (product): 71773-050 ndc (product): 71773-100

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71773-050	Xerava	eravacycline	Tetraphase Pharmaceuticals, Inc.	NDA	Current
71773-050	Xerava	eravacycline	Tetraphase Pharmaceuticals, Inc.	NDA	Current
71773-050	Xerava	eravacycline	Tetraphase Pharmaceuticals, Inc.	NDA	Current
71773-050	Xerava	eravacycline	Tetraphase Pharmaceuticals, Inc.	NDA	Current
71773-050	Xerava	eravacycline	Tetraphase Pharmaceuticals, Inc.	NDA	Current
71773-100	Xerava	eravacycline	Tetraphase Pharmaceuticals, Inc.	NDA	Current
71773-100	Xerava	eravacycline	Tetraphase Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81864	SUPPL	2025-04-08
81798	SUPPL	2025-04-02
80590	SUPPL	2024-12-16
80577	SUPPL	2024-12-16
63656	SUPPL	2020-06-22
55782	ORIG	2018-10-02
55343	ORIG	2018-08-28
55342	ORIG	2018-08-28