Application 214155

Type: NDA
Sponsor: MELINTA THERAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KIMYRSA	ORITAVANCIN DIPHOSPHATE	POWDER;INTRAVENOUS	EQ 1.2GM BASE/VIAL	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
N214155-001	KIMYRSA	ORITAVANCIN DIPHOSPHATE	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2021-03-12

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
N214155-001	12514899	2029-08-29	U-4398		2026-02-03
N214155-001	8420592	2029-08-29	U-3101		2021-04-12
N214155-001	9682061	2030-04-26	U-3101		2021-04-12
N214155-001	9649352	2035-07-16		Drug substance, Drug product	2021-04-12

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	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214155-001	KIMYRSA	EQ 1.2GM BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-03-12	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 109 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	N214155-001	12514899	2029-08-29	U-4398		2026-02-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214155-001	8420592	2029-08-29	U-3101		2021-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214155-001	9682061	2030-04-26	U-3101		2021-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214155-001	9649352	2035-07-16		Drug substance, Drug product	2021-04-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214155-001	12514899	2029-08-29	U-4398		2026-02-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214155-001	8420592	2029-08-29	U-3101		2021-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214155-001	9682061	2030-04-26	U-3101		2021-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214155-001	9649352	2035-07-16		Drug substance, Drug product	2021-04-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214155-001	12514899	2029-08-29	U-4398		2026-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214155-001	8420592	2029-08-29	U-3101		2021-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214155-001	9682061	2030-04-26	U-3101		2021-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214155-001	9649352	2035-07-16		Drug substance, Drug product	2021-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214155-001	8420592	2029-08-29	U-3101		2021-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214155-001	9682061	2030-04-26	U-3101		2021-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214155-001	9649352	2035-07-16		Drug substance, Drug product	2021-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214155-001	8420592	2029-08-29	U-3101		2021-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214155-001	9682061	2030-04-26	U-3101		2021-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214155-001	9649352	2035-07-16		Drug substance, Drug product	2021-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214155-001	8420592	2029-08-29	U-3101		2021-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214155-001	9682061	2030-04-26	U-3101		2021-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214155-001	9649352	2035-07-16		Drug substance, Drug product	2021-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214155-001	8420592	2029-08-29	U-3101		2021-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214155-001	9682061	2030-04-26	U-3101		2021-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214155-001	9649352	2035-07-16		Drug substance, Drug product	2021-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214155-001	8420592	2029-08-29	U-3101		2021-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214155-001	9682061	2030-04-26	U-3101		2021-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214155-001	9649352	2035-07-16		Drug substance, Drug product	2021-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214155-001	8420592	2029-08-29	U-3101		2021-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214155-001	9682061	2030-04-26	U-3101		2021-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214155-001	9649352	2035-07-16		Drug substance, Drug product	2021-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214155-001	8420592	2029-08-29	U-3101		2021-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214155-001	9682061	2030-04-26	U-3101		2021-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214155-001	9649352	2035-07-16		Drug substance, Drug product	2021-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214155-001	8420592	2029-08-29	U-3101		2021-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214155-001	9682061	2030-04-26	U-3101		2021-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214155-001	9649352	2035-07-16		Drug substance, Drug product	2021-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214155-001	8420592	2029-08-29	U-3101		2021-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214155-001	9682061	2030-04-26	U-3101		2021-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214155-001	9649352	2035-07-16		Drug substance, Drug product	2021-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214155-001	8420592	2029-08-29	U-3101		2021-04-12	`79d66fd596c7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214155-001	NCE	2019-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214155-001	NP	2024-03-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214155-001	GAIN	2024-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214155-001	NCE	2019-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214155-001	NP	2024-03-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214155-001	GAIN	2024-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214155-001	NCE	2019-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214155-001	NP	2024-03-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214155-001	GAIN	2024-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214155-001	NCE	2019-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214155-001	NP	2024-03-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214155-001	GAIN	2024-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214155-001	NCE	2019-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214155-001	NP	2024-03-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214155-001	GAIN	2024-08-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214155-001	NCE	2019-08-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214155-001	NP	2024-03-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214155-001	GAIN	2024-08-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214155-001	NCE	2019-08-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214155-001	NP	2024-03-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214155-001	GAIN	2024-08-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214155-001	NCE	2019-08-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214155-001	NP	2024-03-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214155-001	GAIN	2024-08-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214155-001	NCE	2019-08-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214155-001	NP	2024-03-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214155-001	GAIN	2024-08-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214155-001	NCE	2019-08-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214155-001	NP	2024-03-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214155-001	GAIN	2024-08-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214155-001	NCE	2019-08-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214155-001	NP	2024-03-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214155-001	GAIN	2024-08-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214155-001	NCE	2019-08-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N214155-001	NP	2024-03-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N214155-001	GAIN	2024-08-06	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214155-001	NCE	2019-08-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N214155-001	NP	2024-03-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N214155-001	GAIN	2024-08-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214155-001	NCE	2019-08-06	`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
Kimyrsa	ORITAVANCIN DIPHOSPHATE	Melinta Therapeutics, LLC	5e755c40-6e73-4572-b474-4d8a131693d1	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214155 application number: NDA214155 ndc (product): 70842-225

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70842-225	Kimyrsa	oritavancin diphosphate	Melinta Therapeutics, LLC	NDA	Current
70842-225	Kimyrsa	oritavancin diphosphate	Melinta Therapeutics, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82072	SUPPL	2025-04-29
68199	SUPPL	2021-07-27
68186	SUPPL	2021-07-26
66790	ORIG	2021-03-16
66786	ORIG	2021-03-16