Application 211962

Type: NDA
Sponsor: XELLIA PHARMS APS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 500MG BASE/100ML	Yes	Yes
002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 1GM BASE/200ML	Yes	Yes
003	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 1.5GM BASE/300ML	Yes	Yes
004	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 2GM BASE/400ML	Yes	Yes
005	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 750MG BASE/150ML (EQ 5MG BASE/ML)	Yes	Yes
006	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)	Yes	Yes
007	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 1.75GM BASE/350ML (EQ 5MG 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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N211962-001	TYZAVAN	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/100ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15
N211962-002	TYZAVAN	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/200ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15
N211962-003	TYZAVAN	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15
N211962-004	TYZAVAN	VANCOMYCIN HYDROCHLORIDE	EQ 2GM BASE/400ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15
N211962-005	TYZAVAN	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/150ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-05-13
N211962-006	TYZAVAN	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-05-13
N211962-007	TYZAVAN	VANCOMYCIN HYDROCHLORIDE	EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-05-13

Orange Book patents#

Current patent rows page 1 of 1 · 42 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211962-001	10039804	2035-11-06	U-282	Drug product	2019-03-11
N211962-001	10188697	2035-11-06	U-282	Drug product	2019-03-11
N211962-001	10849956	2035-11-06		Drug product	2020-12-10
N211962-001	11517609	2035-11-06	U-282		2022-12-15
N211962-001	11628200	2035-11-06		Drug product	2023-05-09
N211962-001	12161690	2035-11-06		Drug product	2025-01-10
N211962-002	10039804	2035-11-06	U-282	Drug product	2019-03-11
N211962-002	10188697	2035-11-06	U-282	Drug product	2019-03-11
N211962-002	10849956	2035-11-06		Drug product	2020-12-10
N211962-002	11517609	2035-11-06	U-282		2022-12-15
N211962-002	11628200	2035-11-06		Drug product	2023-05-09
N211962-002	12161690	2035-11-06		Drug product	2025-01-10
N211962-003	10039804	2035-11-06	U-282	Drug product	2019-03-11
N211962-003	10188697	2035-11-06	U-282	Drug product	2019-03-11
N211962-003	10849956	2035-11-06		Drug product	2020-12-10
N211962-003	11517609	2035-11-06	U-282		2022-12-15
N211962-003	11628200	2035-11-06		Drug product	2023-05-09
N211962-003	12161690	2035-11-06		Drug product	2025-01-10
N211962-004	10039804	2035-11-06	U-282	Drug product	2019-03-11
N211962-004	10188697	2035-11-06	U-282	Drug product	2019-03-11
N211962-004	10849956	2035-11-06		Drug product	2020-12-10
N211962-004	11517609	2035-11-06	U-282		2022-12-15
N211962-004	11628200	2035-11-06		Drug product	2023-05-09
N211962-004	12161690	2035-11-06		Drug product	2025-01-10
N211962-005	10039804	2035-11-06	U-282	Drug product	2020-05-22
N211962-005	10188697	2035-11-06	U-282	Drug product	2020-05-22
N211962-005	10849956	2035-11-06		Drug product	2020-12-10
N211962-005	11517609	2035-11-06	U-282		2022-12-15
N211962-005	11628200	2035-11-06		Drug product	2023-05-09
N211962-005	12161690	2035-11-06		Drug product	2025-01-10
N211962-006	10039804	2035-11-06	U-282	Drug product	2020-05-22
N211962-006	10188697	2035-11-06	U-282	Drug product	2020-05-22
N211962-006	10849956	2035-11-06		Drug product	2020-12-10
N211962-006	11517609	2035-11-06	U-282		2022-12-15
N211962-006	11628200	2035-11-06		Drug product	2023-05-09
N211962-006	12161690	2035-11-06		Drug product	2025-01-10
N211962-007	10039804	2035-11-06	U-282	Drug product	2020-05-22
N211962-007	10188697	2035-11-06	U-282	Drug product	2020-05-22
N211962-007	10849956	2035-11-06		Drug product	2020-12-10
N211962-007	11517609	2035-11-06	U-282		2022-12-15
N211962-007	11628200	2035-11-06		Drug product	2023-05-09
N211962-007	12161690	2035-11-06		Drug product	2025-01-10

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 8 · 282 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	N211962-001	TYZAVAN	EQ 500MG BASE/100ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-002	TYZAVAN	EQ 1GM BASE/200ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-003	TYZAVAN	EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-004	TYZAVAN	EQ 2GM BASE/400ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-005	TYZAVAN	EQ 750MG BASE/150ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-006	TYZAVAN	EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-007	TYZAVAN	EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211962-001	TYZAVAN	EQ 500MG BASE/100ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211962-002	TYZAVAN	EQ 1GM BASE/200ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211962-003	TYZAVAN	EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211962-004	TYZAVAN	EQ 2GM BASE/400ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211962-005	TYZAVAN	EQ 750MG BASE/150ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211962-006	TYZAVAN	EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211962-007	TYZAVAN	EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211962-001	TYZAVAN	EQ 500MG BASE/100ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211962-002	TYZAVAN	EQ 1GM BASE/200ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211962-003	TYZAVAN	EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211962-004	TYZAVAN	EQ 2GM BASE/400ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211962-005	TYZAVAN	EQ 750MG BASE/150ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211962-006	TYZAVAN	EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211962-007	TYZAVAN	EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211962-001	TYZAVAN	EQ 500MG BASE/100ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211962-002	TYZAVAN	EQ 1GM BASE/200ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211962-003	TYZAVAN	EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211962-004	TYZAVAN	EQ 2GM BASE/400ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211962-005	TYZAVAN	EQ 750MG BASE/150ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211962-006	TYZAVAN	EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211962-007	TYZAVAN	EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211962-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/100ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211962-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/200ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211962-003	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211962-004	VANCOMYCIN HYDROCHLORIDE	EQ 2GM BASE/400ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211962-005	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/150ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211962-006	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211962-007	VANCOMYCIN HYDROCHLORIDE	EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211962-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/100ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211962-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/200ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211962-003	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211962-004	VANCOMYCIN HYDROCHLORIDE	EQ 2GM BASE/400ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211962-005	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/150ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-05-13	`b8a1b40f171c…`

Observed Orange Book patent history#

Patent history page 1 of 31 · 1,201 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	N211962-001	10039804	2035-11-06	U-282	Drug product	2019-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-001	10188697	2035-11-06	U-282	Drug product	2019-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-001	10849956	2035-11-06		Drug product	2020-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-001	11517609	2035-11-06	U-282		2022-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-001	11628200	2035-11-06		Drug product	2023-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-001	12161690	2035-11-06		Drug product	2025-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-002	10039804	2035-11-06	U-282	Drug product	2019-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-002	10188697	2035-11-06	U-282	Drug product	2019-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-002	10849956	2035-11-06		Drug product	2020-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-002	11517609	2035-11-06	U-282		2022-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-002	11628200	2035-11-06		Drug product	2023-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-002	12161690	2035-11-06		Drug product	2025-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-003	10039804	2035-11-06	U-282	Drug product	2019-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-003	10188697	2035-11-06	U-282	Drug product	2019-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-003	10849956	2035-11-06		Drug product	2020-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-003	11517609	2035-11-06	U-282		2022-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-003	11628200	2035-11-06		Drug product	2023-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-003	12161690	2035-11-06		Drug product	2025-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-004	10039804	2035-11-06	U-282	Drug product	2019-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-004	10188697	2035-11-06	U-282	Drug product	2019-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-004	10849956	2035-11-06		Drug product	2020-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-004	11517609	2035-11-06	U-282		2022-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-004	11628200	2035-11-06		Drug product	2023-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-004	12161690	2035-11-06		Drug product	2025-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-005	10039804	2035-11-06	U-282	Drug product	2020-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-005	10188697	2035-11-06	U-282	Drug product	2020-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-005	10849956	2035-11-06		Drug product	2020-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-005	11517609	2035-11-06	U-282		2022-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-005	11628200	2035-11-06		Drug product	2023-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-005	12161690	2035-11-06		Drug product	2025-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-006	10039804	2035-11-06	U-282	Drug product	2020-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-006	10188697	2035-11-06	U-282	Drug product	2020-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-006	10849956	2035-11-06		Drug product	2020-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-006	11517609	2035-11-06	U-282		2022-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-006	11628200	2035-11-06		Drug product	2023-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-006	12161690	2035-11-06		Drug product	2025-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-007	10039804	2035-11-06	U-282	Drug product	2020-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-007	10188697	2035-11-06	U-282	Drug product	2020-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-007	10849956	2035-11-06		Drug product	2020-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211962-007	11517609	2035-11-06	U-282		2022-12-15	`caaa826d4ba7…`

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
TYZAVAN	VANCOMYCIN	Hikma Pharmaceuticals USA Inc.	72e9c5e2-07cc-4a8b-ba64-b2e7619ea560	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211962 application number: NDA211962
Vancomycin	VANCOMYCIN	Xellia Pharmaceuticals USA LLC	60bee69b-be70-412c-9e83-a24a0a8a5e7b	2023-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 211962 application number: NDA211962 ndc (product): 70594-056 ndc (product): 70594-042 ndc (product): 70594-058 ndc (product): 70594-057 ndc (product): 70594-041 ndc (product): 70594-043 ndc (product): 70594-044

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 53 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70594-041	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-041	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-041	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-041	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-041	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-041	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-041	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-041	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-042	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-042	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-042	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-042	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-042	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-042	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-042	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-042	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-043	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-043	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-043	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-043	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-043	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-043	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-043	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-043	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-044	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-044	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-044	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-044	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-044	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-044	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-044	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-044	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-056	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-056	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-056	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-056	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-056	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-056	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-056	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-057	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-057	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-057	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-057	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-057	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-057	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-057	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-058	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-058	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-058	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-058	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-058	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-058	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current
70594-058	Vancomycin	Vancomycin	Xellia Pharmaceuticals USA LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82712	SUPPL	2025-06-30
82701	SUPPL	2025-06-30
82687	SUPPL	2025-06-27
82674	SUPPL	2025-06-27
67663	SUPPL	2021-06-02
67642	SUPPL	2021-06-01
66052	SUPPL	2021-02-01
66034	SUPPL	2021-02-01
64529	SUPPL	2020-09-08
64489	SUPPL	2020-09-04
59836	ORIG	2019-08-23
57729	ORIG	2019-02-21
57704	ORIG	2019-02-19