Application 211673

Type: NDA
Sponsor: NABRIVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XENLETA	LEFAMULIN ACETATE	SOLUTION;INTRAVENOUS	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N211673-001	XENLETA	LEFAMULIN ACETATE	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2019-08-19

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17
N211673-001	8071643	2033-03-25	Drug substance, Drug product	2019-09-17
N211673-001	12121582	2036-06-14	Drug product	2025-05-13

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211673-001	NCE	2024-08-19
N211673-001	GAIN	2029-08-19

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2019-08-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2019-08-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211673-001	XENLETA	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-08-19	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 92 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211673-001	8071643	2033-03-25	Drug substance, Drug product	2019-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211673-001	12121582	2036-06-14	Drug product	2025-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211673-001	8071643	2033-03-25	Drug substance, Drug product	2019-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211673-001	12121582	2036-06-14	Drug product	2025-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211673-001	8071643	2033-03-25	Drug substance, Drug product	2019-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211673-001	12121582	2036-06-14	Drug product	2025-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211673-001	8071643	2033-03-25	Drug substance, Drug product	2019-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211673-001	12121582	2036-06-14	Drug product	2025-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211673-001	8153689	2028-03-19	Drug substance, Drug product	2019-09-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211673-001	8071643	2029-01-16	Drug substance, Drug product	2019-09-17	`4b0b4de00fa7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N211673-001	NCE	2024-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211673-001	GAIN	2029-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211673-001	NCE	2024-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211673-001	GAIN	2029-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211673-001	NCE	2024-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211673-001	GAIN	2029-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211673-001	NCE	2024-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211673-001	GAIN	2029-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211673-001	NCE	2024-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211673-001	GAIN	2029-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211673-001	NCE	2024-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211673-001	GAIN	2029-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211673-001	NCE	2024-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211673-001	GAIN	2029-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211673-001	NCE	2024-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211673-001	GAIN	2029-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211673-001	NCE	2024-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211673-001	GAIN	2029-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211673-001	NCE	2024-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211673-001	GAIN	2029-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211673-001	NCE	2024-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211673-001	GAIN	2029-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211673-001	NCE	2024-08-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211673-001	GAIN	2029-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211673-001	NCE	2024-08-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211673-001	GAIN	2029-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211673-001	NCE	2024-08-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211673-001	GAIN	2029-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211673-001	NCE	2024-08-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211673-001	GAIN	2029-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211673-001	NCE	2024-08-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211673-001	GAIN	2029-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211673-001	NCE	2024-08-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211673-001	GAIN	2029-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211673-001	NCE	2024-08-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211673-001	GAIN	2029-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211673-001	NCE	2024-08-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N211673-001	GAIN	2029-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211673-001	NCE	2024-08-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N211673-001	GAIN	2029-08-19	`bb7c543d1eb4…`

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
Xenleta	LEFAMULIN ACETATE	Meitheal Pharmaceuticals Inc.	eb972ea8-7502-422e-84bb-66cb8e93ca06	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211673 application number: NDA211673

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72000-030	Citric Buffered Normal Saline	anhydrous citric acid	Nabriva Therapeutics US, Inc.	NDA	Current
72000-030	Citric Buffered Normal Saline	anhydrous citric acid	Nabriva Therapeutics US, Inc.	NDA	Current
72000-030	Citric Buffered Normal Saline	anhydrous citric acid	Nabriva Therapeutics US, Inc.	NDA	Current
72000-030	Citric Buffered Normal Saline	anhydrous citric acid	Nabriva Therapeutics US, Inc.	NDA	Current
72000-030	Citric Buffered Normal Saline	anhydrous citric acid	Nabriva Therapeutics US, Inc.	NDA	Current
72000-120	Xenleta	lefamulin acetate	Nabriva Therapeutics US, Inc.	NDA	Current
72000-120	Xenleta	lefamulin acetate	Nabriva Therapeutics US, Inc.	NDA	Current
72000-120	Xenleta	lefamulin acetate	Nabriva Therapeutics US, Inc.	NDA	Current
72000-120	Xenleta	lefamulin acetate	Nabriva Therapeutics US, Inc.	NDA	Current
72000-120	Xenleta	lefamulin acetate	Nabriva Therapeutics US, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66808	SUPPL	2021-03-18
66800	SUPPL	2021-03-17
64890	SUPPL	2020-10-13
60178	ORIG	2019-09-26
59770	ORIG	2019-08-20
59767	ORIG	2019-08-20