Application 204107

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 500MG BASE/VIAL	No	No
002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1GM 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
A204107-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP		2015-12-28
A204107-002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1GM 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
A204107-001	AP
A204107-002	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	A204107-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204107-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204107-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204107-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204107-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204107-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204107-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204107-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204107-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204107-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204107-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204107-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204107-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204107-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204107-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204107-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204107-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204107-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204107-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204107-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204107-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204107-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204107-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204107-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204107-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204107-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204107-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204107-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204107-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204107-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204107-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204107-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204107-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204107-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204107-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204107-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204107-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204107-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204107-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2015-12-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204107-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM 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	A204107-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204107-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204107-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204107-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204107-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204107-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204107-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204107-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204107-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204107-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204107-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204107-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204107-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204107-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204107-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204107-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204107-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204107-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204107-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204107-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204107-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204107-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204107-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204107-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204107-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204107-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204107-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204107-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204107-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204107-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204107-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204107-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204107-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204107-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204107-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204107-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204107-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204107-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204107-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204107-002	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 · 5 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	f604d399-fded-4f4f-8efe-af558ed07b9d	2025-05-15	Warnings, Adverse reactions	Exact identifier ndc (product): 63323-221 ndc (product): 63323-284
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	83ea3faf-fedd-4725-911f-d71a23ec5d5e	2024-10-15	Warnings, Adverse reactions	Exact identifier ndc (product): 63323-284
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	0576803d-95de-4a48-806a-69ae3fcaf6b0	2023-08-17	Warnings, Adverse reactions	Exact identifier ndc (product): 63323-221 ndc (product): 63323-284
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi, LLC	8a35ebee-8650-4ef5-84f5-ab9b55d9bc19	2022-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204107 application number: ANDA204107 ndc (product): 63323-221
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi, LLC	418c3c6a-d08d-448c-89c9-54e558c1ce16	2022-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204107 application number: ANDA204107 ndc (product): 63323-221 ndc (product): 63323-284

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-221	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi, LLC	ANDA	Current
63323-221	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi, LLC	ANDA	Current
63323-221	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi, LLC	ANDA	Current
63323-221	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi, LLC	ANDA	Current
63323-221	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi, LLC	ANDA	Current
63323-221	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi, LLC	ANDA	Current
63323-221	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi, LLC	ANDA	Current
63323-284	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi, LLC	ANDA	Current
63323-284	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi, LLC	ANDA	Current
63323-284	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Fresenius Kabi, LLC	ANDA	Current
68001-465	Vancomycin Hydrochloride	vancomycin hydrochloride	BluePoint Laboratories	ANDA	Current
68001-465	Vancomycin Hydrochloride	vancomycin hydrochloride	BluePoint Laboratories	ANDA	Current
68001-465	Vancomycin Hydrochloride	vancomycin hydrochloride	BluePoint Laboratories	ANDA	Current
68001-466	Vancomycin Hydrochloride	vancomycin hydrochloride	BluePoint Laboratories	ANDA	Current
68001-466	Vancomycin Hydrochloride	vancomycin hydrochloride	BluePoint Laboratories	ANDA	Current
68001-466	Vancomycin Hydrochloride	vancomycin hydrochloride	BluePoint Laboratories	ANDA	Current
70594-045	Vancomycin Hydrochloride	vancomycin hydrochloride	Xellia Pharmaceuticals USA LLC	ANDA	Current
70594-045	Vancomycin Hydrochloride	vancomycin hydrochloride	Xellia Pharmaceuticals USA LLC	ANDA	Current
70594-045	Vancomycin Hydrochloride	vancomycin hydrochloride	Xellia Pharmaceuticals USA LLC	ANDA	Current
70594-045	Vancomycin Hydrochloride	vancomycin hydrochloride	Xellia Pharmaceuticals USA LLC	ANDA	Current
70594-045	Vancomycin Hydrochloride	vancomycin hydrochloride	Xellia Pharmaceuticals USA LLC	ANDA	Current
70594-046	Vancomycin Hydrochloride	vancomycin hydrochloride	Xellia Pharmaceuticals USA LLC	ANDA	Current
70594-046	Vancomycin Hydrochloride	vancomycin hydrochloride	Xellia Pharmaceuticals USA LLC	ANDA	Current
70594-046	Vancomycin Hydrochloride	vancomycin hydrochloride	Xellia Pharmaceuticals USA LLC	ANDA	Current
70594-046	Vancomycin Hydrochloride	vancomycin hydrochloride	Xellia Pharmaceuticals USA LLC	ANDA	Current
70594-046	Vancomycin Hydrochloride	vancomycin hydrochloride	Xellia Pharmaceuticals USA LLC	ANDA	Current
72572-801	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Civica Rx	ANDA	Current
72572-801	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Civica, Inc.	ANDA	Current
72572-801	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Civica, Inc.	ANDA	Current
72572-801	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Civica, Inc.	ANDA	Current
72572-801	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Civica, Inc.	ANDA	Current
72572-801	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Civica, Inc.	ANDA	Current