Application 209776

Type: NDA
Sponsor: REMPEX PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VABOMERE	MEROPENEM; VABORBACTAM	POWDER;INTRAVENOUS	1GM/VIAL;1GM/VIAL	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
N209776-001	VABOMERE	MEROPENEM; VABORBACTAM	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS		RLD, RS	2017-08-29

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209776-001	10172874	2031-08-08		Drug product	2019-02-21
N209776-001	10183034	2031-08-08	U-2490		2019-02-21
N209776-001	10561675	2031-08-08	U-2490		2020-03-18
N209776-001	11007206	2031-08-08	U-3128		2021-06-16
N209776-001	12171772	2031-08-08		Drug substance	2025-01-03
N209776-001	9694025	2031-08-08	U-2120		2017-09-27
N209776-001	8680136	2031-08-29		Drug substance, Drug product	2017-09-27
N209776-001	12478606	2038-01-08	U-3421		2025-12-08
N209776-001	11376237	2039-04-06	U-3421		2022-09-21
N209776-001	12533342	2039-04-06	U-3421		2026-01-29

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N209776-001	NCE	2022-08-29
N209776-001	GAIN	2027-08-29

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 · 42 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	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209776-001	VABOMERE	1GM/VIAL;1GM/VIAL	POWDER / INTRAVENOUS	RLD, RS	2017-08-29	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 282 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209776-001	10172874	2031-08-08		Drug product	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209776-001	10183034	2031-08-08	U-2490		2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209776-001	10561675	2031-08-08	U-2490		2020-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209776-001	11007206	2031-08-08	U-3128		2021-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209776-001	12171772	2031-08-08		Drug substance	2025-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209776-001	9694025	2031-08-08	U-2120		2017-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209776-001	8680136	2031-08-29		Drug substance, Drug product	2017-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209776-001	12478606	2038-01-08	U-3421		2025-12-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209776-001	11376237	2039-04-06	U-3421		2022-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209776-001	12533342	2039-04-06	U-3421		2026-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209776-001	10172874	2031-08-08		Drug product	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209776-001	10183034	2031-08-08	U-2490		2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209776-001	10561675	2031-08-08	U-2490		2020-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209776-001	11007206	2031-08-08	U-3128		2021-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209776-001	12171772	2031-08-08		Drug substance	2025-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209776-001	9694025	2031-08-08	U-2120		2017-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209776-001	8680136	2031-08-29		Drug substance, Drug product	2017-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209776-001	12478606	2038-01-08	U-3421		2025-12-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209776-001	11376237	2039-04-06	U-3421		2022-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209776-001	12533342	2039-05-20	U-3421		2026-01-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209776-001	10172874	2031-08-08		Drug product	2019-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209776-001	10183034	2031-08-08	U-2490		2019-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209776-001	10561675	2031-08-08	U-2490		2020-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209776-001	11007206	2031-08-08	U-3128		2021-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209776-001	12171772	2031-08-08		Drug substance	2025-01-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209776-001	9694025	2031-08-08	U-2120		2017-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209776-001	8680136	2031-08-29		Drug substance, Drug product	2017-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209776-001	12478606	2038-01-08	U-3421		2025-12-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209776-001	11376237	2039-04-06	U-3421		2022-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209776-001	10172874	2031-08-08		Drug product	2019-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209776-001	10183034	2031-08-08	U-2490		2019-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209776-001	10561675	2031-08-08	U-2490		2020-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209776-001	11007206	2031-08-08	U-3128		2021-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209776-001	12171772	2031-08-08		Drug substance	2025-01-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209776-001	9694025	2031-08-08	U-2120		2017-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209776-001	8680136	2031-08-29		Drug substance, Drug product	2017-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209776-001	11376237	2039-04-06	U-3421		2022-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209776-001	10172874	2031-08-08		Drug product	2019-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209776-001	10183034	2031-08-08	U-2490		2019-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209776-001	10561675	2031-08-08	U-2490		2020-03-18	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 68 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	N209776-001	NCE	2022-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209776-001	GAIN	2027-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209776-001	NCE	2022-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209776-001	GAIN	2027-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209776-001	NCE	2022-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209776-001	GAIN	2027-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209776-001	NCE	2022-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209776-001	GAIN	2027-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209776-001	NCE	2022-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209776-001	GAIN	2027-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209776-001	NCE	2022-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209776-001	GAIN	2027-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209776-001	NCE	2022-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209776-001	GAIN	2027-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209776-001	NCE	2022-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209776-001	GAIN	2027-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209776-001	NCE	2022-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209776-001	GAIN	2027-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209776-001	NCE	2022-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209776-001	GAIN	2027-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209776-001	NCE	2022-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209776-001	GAIN	2027-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209776-001	NCE	2022-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209776-001	GAIN	2027-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209776-001	NCE	2022-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209776-001	GAIN	2027-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209776-001	NCE	2022-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209776-001	GAIN	2027-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209776-001	NCE	2022-08-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209776-001	GAIN	2027-08-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209776-001	NCE	2022-08-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209776-001	GAIN	2027-08-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209776-001	NCE	2022-08-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209776-001	GAIN	2027-08-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209776-001	NCE	2022-08-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209776-001	GAIN	2027-08-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N209776-001	NCE	2022-08-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209776-001	GAIN	2027-08-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209776-001	NCE	2022-08-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209776-001	GAIN	2027-08-29	`782e0a99824c…`

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
VABOMERE	MEROPENEM-VABORBACTAM	Melinta Therapeutics, LLC	e237fd0f-3050-42a3-b43e-b6fb4824e93d	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209776 application number: NDA209776 ndc (product): 70842-120

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65293-009	VABOMERE	Meropenem-Vaborbactam	The Medicines Company	NDA	Current
70842-120	VABOMERE	Meropenem-Vaborbactam	Melinta Therapeutics, Inc.	NDA	Current
70842-120	VABOMERE	Meropenem-Vaborbactam	Melinta Therapeutics, Inc.	NDA	Current
70842-120	VABOMERE	Meropenem-Vaborbactam	Melinta Therapeutics, Inc.	NDA	Current
70842-120	VABOMERE	Meropenem-Vaborbactam	Melinta Therapeutics, LLC	NDA	Current
70842-120	VABOMERE	Meropenem-Vaborbactam	Melinta Therapeutics, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85130	SUPPL	2026-02-24
85111	SUPPL	2026-02-24
80519	SUPPL	2024-12-05
80499	SUPPL	2024-12-04
75542	SUPPL	2023-09-22
75531	SUPPL	2023-09-22
63339	SUPPL	2020-05-29
63324	SUPPL	2020-05-28
54883	SUPPL	2018-07-13
54864	SUPPL	2018-07-09
49936	ORIG	2017-10-04
49614	ORIG	2017-08-30
49613	ORIG	2017-08-30