Application 208910

Type: NDA
Sponsor: RXMTM THERAPS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FIRVANQ KIT	VANCOMYCIN HYDROCHLORIDE	FOR SOLUTION;ORAL	EQ 25MG BASE/ML	Yes	Yes
002	FIRVANQ KIT	VANCOMYCIN HYDROCHLORIDE	FOR SOLUTION;ORAL	EQ 50MG BASE/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N208910-001	FIRVANQ KIT	VANCOMYCIN HYDROCHLORIDE	EQ 25MG BASE/ML	FOR SOLUTION / ORAL	AA	RLD, RS	2018-01-26
N208910-002	FIRVANQ KIT	VANCOMYCIN HYDROCHLORIDE	EQ 50MG BASE/ML	FOR SOLUTION / ORAL	AA	RLD, RS	2018-01-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N208910-001	AA
N208910-002	AA

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208910-001	10493028	2035-03-13		Drug product	2019-12-05
N208910-001	10688046	2035-03-13		Drug product	2020-07-10
N208910-001	10959946	2035-03-13		Drug product	2021-04-15
N208910-001	10959947	2035-03-13	U-3104	Drug product	2021-04-15
N208910-001	10959947	2035-03-13	U-3105	Drug product	2021-04-15
N208910-001	10959948	2035-03-13	U-3104	Drug product	2021-04-15
N208910-001	10959948	2035-03-13	U-3105	Drug product	2021-04-15
N208910-001	10959949	2035-03-13	U-3104	Drug product	2021-04-15
N208910-001	10959949	2035-03-13	U-3105	Drug product	2021-04-15
N208910-001	11638692	2035-03-13		Drug product	2023-05-02
N208910-002	10493028	2035-03-13		Drug product	2019-12-05
N208910-002	10688046	2035-03-13		Drug product	2020-07-10
N208910-002	10959946	2035-03-13		Drug product	2021-04-15
N208910-002	10959947	2035-03-13	U-3104	Drug product	2021-04-15
N208910-002	10959947	2035-03-13	U-3105	Drug product	2021-04-15
N208910-002	10959948	2035-03-13	U-3104	Drug product	2021-04-15
N208910-002	10959948	2035-03-13	U-3105	Drug product	2021-04-15
N208910-002	10959949	2035-03-13	U-3104	Drug product	2021-04-15
N208910-002	10959949	2035-03-13	U-3105	Drug product	2021-04-15
N208910-002	11638692	2035-03-13		Drug product	2023-05-02

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208910-001	FIRVANQ KIT	EQ 25MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-002	FIRVANQ KIT	EQ 50MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-001	FIRVANQ KIT	EQ 25MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-002	FIRVANQ KIT	EQ 50MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208910-001	FIRVANQ KIT	EQ 25MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208910-002	FIRVANQ KIT	EQ 50MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208910-001	FIRVANQ KIT	EQ 25MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208910-002	FIRVANQ KIT	EQ 50MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208910-001	FIRVANQ KIT	EQ 25MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208910-002	FIRVANQ KIT	EQ 50MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208910-001	FIRVANQ KIT	EQ 25MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208910-002	FIRVANQ KIT	EQ 50MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208910-001	FIRVANQ KIT	EQ 25MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208910-002	FIRVANQ KIT	EQ 50MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208910-001	FIRVANQ KIT	EQ 25MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208910-002	FIRVANQ KIT	EQ 50MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208910-001	FIRVANQ KIT	EQ 25MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208910-002	FIRVANQ KIT	EQ 50MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208910-001	FIRVANQ KIT	EQ 25MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208910-002	FIRVANQ KIT	EQ 50MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208910-001	FIRVANQ KIT	EQ 25MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208910-002	FIRVANQ KIT	EQ 50MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208910-001	FIRVANQ KIT	EQ 25MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208910-002	FIRVANQ KIT	EQ 50MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208910-001	FIRVANQ KIT	EQ 25MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208910-002	FIRVANQ KIT	EQ 50MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208910-001	FIRVANQ KIT	EQ 25MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208910-002	FIRVANQ KIT	EQ 50MG BASE/ML	FOR SOLUTION / ORAL	AB	RLD, RS	2018-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208910-001	FIRVANQ KIT	EQ 25MG BASE/ML	FOR SOLUTION / ORAL		RLD, RS	2018-01-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208910-002	FIRVANQ KIT	EQ 50MG BASE/ML	FOR SOLUTION / ORAL		RLD, RS	2018-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208910-001	FIRVANQ KIT	EQ 25MG BASE/ML	FOR SOLUTION / ORAL		RLD, RS	2018-01-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208910-002	FIRVANQ KIT	EQ 50MG BASE/ML	FOR SOLUTION / ORAL		RLD, RS	2018-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208910-001	FIRVANQ KIT	EQ 25MG BASE/ML	FOR SOLUTION / ORAL		RLD, RS	2018-01-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208910-002	FIRVANQ KIT	EQ 50MG BASE/ML	FOR SOLUTION / ORAL		RLD, RS	2018-01-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208910-001	FIRVANQ KIT	EQ 25MG BASE/ML	FOR SOLUTION / ORAL		RLD, RS	2018-01-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208910-002	FIRVANQ KIT	EQ 50MG BASE/ML	FOR SOLUTION / ORAL		RLD, RS	2018-01-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208910-001	FIRVANQ KIT	EQ 25MG BASE/ML	FOR SOLUTION / ORAL		RLD, RS	2018-01-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208910-002	FIRVANQ KIT	EQ 50MG BASE/ML	FOR SOLUTION / ORAL		RLD, RS	2018-01-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208910-001	FIRVANQ KIT	EQ 25MG BASE/ML	FOR SOLUTION / ORAL		RLD, RS	2018-01-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208910-002	FIRVANQ KIT	EQ 50MG BASE/ML	FOR SOLUTION / ORAL		RLD, RS	2018-01-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208910-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208910-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208910-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208910-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208910-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208910-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208910-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208910-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208910-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208910-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208910-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208910-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208910-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208910-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208910-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208910-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208910-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208910-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208910-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208910-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208910-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208910-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208910-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208910-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208910-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208910-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208910-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208910-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N208910-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208910-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N208910-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208910-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208910-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208910-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208910-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208910-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208910-002	AB	1	`a67488948f0b…`

Observed Orange Book patent history#

Patent history page 1 of 17 · 656 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208910-001	10493028	2035-03-13		Drug product	2019-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-001	10688046	2035-03-13		Drug product	2020-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-001	10959946	2035-03-13		Drug product	2021-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-001	10959947	2035-03-13	U-3105	Drug product	2021-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-001	10959947	2035-03-13	U-3104	Drug product	2021-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-001	10959948	2035-03-13	U-3105	Drug product	2021-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-001	10959948	2035-03-13	U-3104	Drug product	2021-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-001	10959949	2035-03-13	U-3104	Drug product	2021-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-001	10959949	2035-03-13	U-3105	Drug product	2021-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-001	11638692	2035-03-13		Drug product	2023-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-002	10493028	2035-03-13		Drug product	2019-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-002	10688046	2035-03-13		Drug product	2020-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-002	10959946	2035-03-13		Drug product	2021-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-002	10959947	2035-03-13	U-3104	Drug product	2021-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-002	10959947	2035-03-13	U-3105	Drug product	2021-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-002	10959948	2035-03-13	U-3104	Drug product	2021-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-002	10959948	2035-03-13	U-3105	Drug product	2021-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-002	10959949	2035-03-13	U-3105	Drug product	2021-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-002	10959949	2035-03-13	U-3104	Drug product	2021-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208910-002	11638692	2035-03-13		Drug product	2023-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-001	10493028	2035-03-13		Drug product	2019-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-001	10688046	2035-03-13		Drug product	2020-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-001	10959946	2035-03-13		Drug product	2021-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-001	10959947	2035-03-13	U-3105	Drug product	2021-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-001	10959947	2035-03-13	U-3104	Drug product	2021-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-001	10959948	2035-03-13	U-3105	Drug product	2021-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-001	10959948	2035-03-13	U-3104	Drug product	2021-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-001	10959949	2035-03-13	U-3104	Drug product	2021-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-001	10959949	2035-03-13	U-3105	Drug product	2021-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-001	11638692	2035-03-13		Drug product	2023-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-002	10493028	2035-03-13		Drug product	2019-12-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-002	10688046	2035-03-13		Drug product	2020-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-002	10959946	2035-03-13		Drug product	2021-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-002	10959947	2035-03-13	U-3104	Drug product	2021-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-002	10959947	2035-03-13	U-3105	Drug product	2021-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-002	10959948	2035-03-13	U-3104	Drug product	2021-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-002	10959948	2035-03-13	U-3105	Drug product	2021-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-002	10959949	2035-03-13	U-3105	Drug product	2021-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-002	10959949	2035-03-13	U-3104	Drug product	2021-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208910-002	11638692	2035-03-13		Drug product	2023-05-02	`31067a03dcf5…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FIRVANQ	VANCOMYCIN HYDROCHLORIDE	Azurity Pharmaceuticals, Inc	5aca5508-b577-446c-9980-ab4c7582b4b9	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208910 application number: NDA208910 ndc (product): 65628-208 ndc (product): 65628-204 ndc (product): 65628-206 ndc (product): 65628-205
Vancomycin Hydrochloride for Oral Solution	VANCOMYCIN HYDROCHLORIDE	Wilshire Pharmaceuticals, Inc.	4c3d2e99-5351-4442-916a-d2001b0a5f5a	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208910 application number: NDA208910

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65628-015	FIRVANQ	vancomycin hydrochloride	Azurity Pharmaceuticals, Inc	NDA	Current
65628-015	FIRVANQ	vancomycin hydrochloride	Azurity Pharmaceuticals, Inc	NDA	Current
65628-015	FIRVANQ	Vancomycin hydrochloride	CutisPharma, Inc.	NDA	Current
65628-015	FIRVANQ	Vancomycin hydrochloride	CutisPharma, Inc.	NDA	Current
65628-016	FIRVANQ	vancomycin hydrochloride	Azurity Pharmaceuticals, Inc	NDA	Current
65628-016	FIRVANQ	vancomycin hydrochloride	Azurity Pharmaceuticals, Inc	NDA	Current
65628-016	FIRVANQ	Vancomycin hydrochloride	CutisPharma, Inc.	NDA	Current
65628-016	FIRVANQ	Vancomycin hydrochloride	CutisPharma, Inc.	NDA	Current
65628-204	FIRVANQ	vancomycin hydrochloride	Azurity Pharmaceuticals, Inc	NDA	Current
65628-204	FIRVANQ	Vancomycin hydrochloride	CutisPharma, Inc.	NDA	Current
65628-204	FIRVANQ	vancomycin hydrochloride	Azurity Pharmaceuticals, Inc	NDA	Current
65628-204	FIRVANQ	Vancomycin hydrochloride	CutisPharma, Inc.	NDA	Current
65628-204	FIRVANQ	vancomycin hydrochloride	Azurity Pharmaceuticals, Inc	NDA	Current
65628-205	FIRVANQ	vancomycin hydrochloride	Azurity Pharmaceuticals, Inc	NDA	Current
65628-205	FIRVANQ	Vancomycin hydrochloride	CutisPharma, Inc.	NDA	Current
65628-205	FIRVANQ	vancomycin hydrochloride	Azurity Pharmaceuticals, Inc	NDA	Current
65628-205	FIRVANQ	Vancomycin hydrochloride	CutisPharma, Inc.	NDA	Current
65628-205	FIRVANQ	vancomycin hydrochloride	Azurity Pharmaceuticals, Inc	NDA	Current
65628-206	FIRVANQ	vancomycin hydrochloride	Azurity Pharmaceuticals, Inc	NDA	Current
65628-206	FIRVANQ	Vancomycin hydrochloride	CutisPharma, Inc.	NDA	Current
65628-206	FIRVANQ	vancomycin hydrochloride	Azurity Pharmaceuticals, Inc	NDA	Current
65628-206	FIRVANQ	Vancomycin hydrochloride	CutisPharma, Inc.	NDA	Current
65628-206	FIRVANQ	vancomycin hydrochloride	Azurity Pharmaceuticals, Inc	NDA	Current
65628-208	FIRVANQ	vancomycin hydrochloride	Azurity Pharmaceuticals, Inc	NDA	Current
65628-208	FIRVANQ	Vancomycin hydrochloride	CutisPharma, Inc.	NDA	Current
65628-208	FIRVANQ	vancomycin hydrochloride	Azurity Pharmaceuticals, Inc	NDA	Current
65628-208	FIRVANQ	Vancomycin hydrochloride	CutisPharma, Inc.	NDA	Current
65628-208	FIRVANQ	vancomycin hydrochloride	Azurity Pharmaceuticals, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70182	SUPPL	2022-02-17
66049	SUPPL	2021-02-01
66032	SUPPL	2021-02-01
61296	SUPPL	2019-12-17
55860	ORIG	2018-10-10
52130	ORIG	2018-01-30
52084	ORIG	2018-01-30