Application 204125

Type: ANDA
Sponsor: XELLIA PHARMS APS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 5GM BASE/VIAL	No	No
002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	No	No

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

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
A204125-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2015-12-28
A204125-002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP		2015-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204125-001	AP
A204125-002	AP

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204125-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204125-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204125-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204125-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204125-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204125-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204125-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204125-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204125-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204125-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204125-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204125-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204125-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204125-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204125-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204125-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204125-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204125-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204125-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204125-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204125-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204125-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204125-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204125-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204125-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204125-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204125-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204125-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204125-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204125-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204125-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204125-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204125-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204125-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204125-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204125-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204125-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204125-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204125-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204125-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204125-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204125-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204125-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204125-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204125-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204125-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204125-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204125-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204125-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204125-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204125-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204125-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204125-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204125-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204125-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204125-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204125-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204125-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204125-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204125-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204125-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204125-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204125-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204125-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204125-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204125-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204125-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204125-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204125-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204125-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204125-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204125-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204125-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204125-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204125-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204125-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204125-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204125-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204125-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204125-002	AP	1	`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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	0713a847-a334-4b73-af22-343aa06621b9	2023-02-07	Warnings, Adverse reactions	Exact identifier ndc (product): 63323-314
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	BluePoint Laboratories	f28e3c2b-ae31-4c2a-8178-53962b7b213c	2022-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204125 application number: ANDA204125 ndc (product): 68001-406 ndc (product): 68001-407
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	d3147f2d-1a72-4923-874b-8fdee2be625e	2021-09-30	Warnings, Adverse reactions	Exact identifier ndc (product): 63323-314
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi, LLC	a7e7d990-1d74-459b-ac07-d1c3e13b3204	2019-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204125 application number: ANDA204125 ndc (product): 63323-314

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-314	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi, LLC	ANDA	Current
68001-406	Vancomycin Hydrochloride	Vancomycin Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-406	Vancomycin Hydrochloride	Vancomycin Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-406	Vancomycin Hydrochloride	Vancomycin Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-406	Vancomycin Hydrochloride	Vancomycin Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-406	Vancomycin Hydrochloride	Vancomycin Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-407	Vancomycin Hydrochloride	Vancomycin Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-407	Vancomycin Hydrochloride	Vancomycin Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-407	Vancomycin Hydrochloride	Vancomycin Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-407	Vancomycin Hydrochloride	Vancomycin Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-407	Vancomycin Hydrochloride	Vancomycin Hydrochloride	BluePoint Laboratories	ANDA	Current
70594-047	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Xellia Pharmaceuticals USA LLC	ANDA	Current
70594-047	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Xellia Pharmaceuticals USA LLC	ANDA	Current
70594-047	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Xellia Pharmaceuticals USA LLC	ANDA	Current
70594-047	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Xellia Pharmaceuticals USA LLC	ANDA	Current
70594-048	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Xellia Pharmaceuticals USA LLC	ANDA	Current
70594-048	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Xellia Pharmaceuticals USA LLC	ANDA	Current
70594-048	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Xellia Pharmaceuticals US	ANDA	Current
70594-048	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Xellia Pharmaceuticals USA LLC	ANDA	Current
70594-048	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Xellia Pharmaceuticals USA LLC	ANDA	Current
72572-803	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Civica, Inc.	ANDA	Current
72572-803	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Civica, Inc.	ANDA	Current
72572-805	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Civica, Inc.	ANDA	Current
72572-805	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Civica, Inc.	ANDA	Current