Application 206243

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 43.

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
A206243-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION			2015-12-23
A206243-002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2015-12-23

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206243-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206243-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206243-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206243-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206243-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206243-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206243-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206243-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206243-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206243-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206243-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206243-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206243-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206243-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206243-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206243-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206243-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206243-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206243-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206243-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206243-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206243-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206243-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206243-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206243-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206243-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206243-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206243-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206243-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206243-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206243-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206243-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206243-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206243-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206243-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206243-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206243-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206243-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206243-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206243-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	2015-12-23	`74a2ff9319b5…`

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 3 of 4 · 78 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	HIKMA PHARMACEUTICALS USA INC.	8eccafe8-40c9-495a-872d-7f45a98ee759	2025-08-13	Warnings, Adverse reactions	Name fallback brand name: VANCOMYCIN HYDROCHLORIDE generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Sagent Pharmaceuticals	f623889c-a47a-4b3a-b3a9-e04051f5c2df	2025-05-28	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	f604d399-fded-4f4f-8efe-af558ed07b9d	2025-05-15	Warnings, Adverse reactions	Name fallback brand name: VANCOMYCIN HYDROCHLORIDE generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Gland Pharma Limited	65e5f2ee-934c-40d7-967c-00d085f84ffd	2025-04-24	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
vancomycin hydrochloride	VANCOMYCIN HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	33127951-1fad-15c1-e063-6294a90a6996	2025-04-18	Warnings, Adverse reactions	Name fallback brand name: vancomycin hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	b62b7190-48e8-4596-a6ad-9ad455e5c8c6	2025-03-21	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	9bfe30f8-c662-4af3-bc82-f0102eef8952	2025-03-17	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hospira, Inc.	91c050cf-3b2d-48bc-7297-e8dc68225e5a	2025-01-16	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	83ea3faf-fedd-4725-911f-d71a23ec5d5e	2024-10-15	Warnings, Adverse reactions	Name fallback brand name: VANCOMYCIN HYDROCHLORIDE generic name: VANCOMYCIN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	HIKMA PHARMACEUTICALS USA INC.	e4ce7b87-fab4-4b7a-b121-eba136c464ce	2024-08-07	Warnings, Adverse reactions	Name fallback brand name: VANCOMYCIN HYDROCHLORIDE generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin	VANCOMYCIN HYDROCHLORIDE	Sagent Pharmaceuticals	06dcfd36-942f-4752-86ad-4c5a6fc3e48f	2024-07-19	Warnings, Adverse reactions	Name fallback generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Eugia US LLC	4a80cb3f-7410-47aa-af1f-ff83d1b35c55	2024-07-08	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Eugia US LLC	78984781-3c0b-4b73-ba85-10d60ecb2a28	2024-07-08	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Mylan Institutional LLC	40a88420-5fcb-4715-abc5-595a18fd08d0	2024-06-07	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Mylan Institutional LLC	caf22ccb-df75-45ea-a1d0-ccb2d37272fb	2024-06-07	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Xellia Pharmaceuticals USA LLC	8403695c-3614-490b-9797-6c5ebcdeef9b	2023-12-12	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	45642a47-4712-4a12-8cf7-ee6c2ab8e6c6	2023-09-29	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	0576803d-95de-4a48-806a-69ae3fcaf6b0	2023-08-17	Warnings, Adverse reactions	Name fallback brand name: VANCOMYCIN HYDROCHLORIDE generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin hydrochloride	VANCOMYCIN HYDROCHLORIDE	Eugia US LLC	9aa42538-c84e-4886-8d3d-a7dfded5120f	2023-08-05	Warnings, Adverse reactions	Name fallback brand name: Vancomycin hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Gland Pharma Limited	35ecffbc-77d8-4c0d-9b14-6a3cc442dec6	2023-07-13	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE

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
45932-0031	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Xellia Pharmaceuticals ApS	ANDA	Current
45932-0032	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Xellia Pharmaceuticals ApS	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10552	ORIG	2015-12-30