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 4 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	Sagent Pharmaceuticals	4843726f-6e79-6e20-2620-4a54616e6479	2023-06-29	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Ascend Laboratories, LLC	b9a7c728-750b-467f-bf61-54dd836dba1b	2023-06-28	Warnings, Adverse reactions	Name fallback brand name: VANCOMYCIN HYDROCHLORIDE generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	3c47d5c4-8cdb-4701-8d7a-8a6e79025b53	2023-06-23	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin hydrochloride	VANCOMYCIN HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	e5e26614-4119-40cc-b092-48ab97a41287	2023-03-27	Warnings, Adverse reactions	Name fallback brand name: Vancomycin hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	0713a847-a334-4b73-af22-343aa06621b9	2023-02-07	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi, LLC	8a35ebee-8650-4ef5-84f5-ab9b55d9bc19	2022-12-02	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi, LLC	418c3c6a-d08d-448c-89c9-54e558c1ce16	2022-12-02	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	BluePoint Laboratories	f28e3c2b-ae31-4c2a-8178-53962b7b213c	2022-09-22	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Camber Pharmaceuticals, Inc.	3f5dacea-af40-4103-b128-c5e0c0c52fa1	2022-07-20	Warnings, Adverse reactions	Name fallback brand name: VANCOMYCIN HYDROCHLORIDE generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	86950e7c-0114-47e9-8891-e09e595c48c3	2022-02-25	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	cae9e5f3-b89a-4a7f-93f7-9471c74a3559	2021-12-07	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	d3147f2d-1a72-4923-874b-8fdee2be625e	2021-09-30	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Mylan Institutional LLC	ce139a51-0471-4c31-b456-2f889f18dd2b	2021-09-15	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	2f5d3131-8ddc-43a5-91f7-947c531796e7	2021-06-02	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Mylan Institutional LLC	2dc7b3d6-3874-40ac-b8aa-7bcfe2dc0cdf	2021-06-01	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
vancomycin hydrochloride	VANCOMYCIN HYDROCHLORIDE	Mylan Institutional LLC	3843d0d7-f70a-4b29-9478-dfb45b02425e	2021-06-01	Warnings, Adverse reactions	Name fallback brand name: vancomycin hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	SAMSON MEDICAL TECHNOLOGIES LLC	93589e71-3a11-4797-9176-8abdb7674a87	2020-11-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi, LLC	a7e7d990-1d74-459b-ac07-d1c3e13b3204	2019-01-09	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