Application 205694

Type: ANDA
Sponsor: GLAND PHARMA LTD

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
003	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 5GM BASE/VIAL	No	No
004	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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205694-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21
A205694-002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21
A205694-003	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06
A205694-004	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A205694-001	AP
A205694-002	AP
A205694-003	AP
A205694-004	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 4 · 130 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	A205694-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205694-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205694-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205694-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205694-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205694-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205694-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205694-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205694-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205694-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205694-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205694-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205694-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205694-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205694-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205694-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205694-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205694-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205694-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205694-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205694-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205694-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205694-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205694-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205694-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205694-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205694-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205694-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205694-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205694-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205694-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205694-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205694-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205694-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205694-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205694-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205694-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205694-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205694-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205694-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 130 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	A205694-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205694-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205694-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205694-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205694-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205694-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205694-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205694-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205694-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205694-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205694-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205694-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205694-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205694-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205694-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205694-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205694-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205694-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205694-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205694-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205694-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205694-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205694-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205694-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205694-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205694-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205694-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205694-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205694-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205694-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205694-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205694-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205694-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205694-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205694-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205694-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205694-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205694-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205694-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205694-004	AP	1	`d8e5a09893c0…`

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	GLENMARK PHARMACEUTICALS INC., USA	74056e26-57fd-448e-af76-edbccfc3efb7	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205694 application number: ANDA205694
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Gland Pharma Limited	00946db3-d6c5-4534-a870-1ec6e63eda43	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205694 application number: ANDA205694 ndc (product): 68083-144 ndc (product): 68083-143
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Xellia Pharmaceuticals USA LLC	8403695c-3614-490b-9797-6c5ebcdeef9b	2023-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205694 application number: ANDA205694
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Gland Pharma Limited	35ecffbc-77d8-4c0d-9b14-6a3cc442dec6	2023-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205694 application number: ANDA205694
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Sagent Pharmaceuticals	4843726f-6e79-6e20-2620-4a54616e6479	2023-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205694 application number: ANDA205694

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47781-597	Vancomycin Hydrochloride	vancomycin hydrochloride	Alvogen Inc.	ANDA	Current
47781-597	Vancomycin Hydrochloride	vancomycin hydrochloride	Alvogen Inc.	ANDA	Current
47781-597	Vancomycin Hydrochloride	vancomycin hydrochloride	Alvogen Inc.	ANDA	Current
47781-598	Vancomycin Hydrochloride	vancomycin hydrochloride	Alvogen Inc.	ANDA	Current
47781-598	Vancomycin Hydrochloride	vancomycin hydrochloride	Alvogen Inc.	ANDA	Current
47781-598	Vancomycin Hydrochloride	vancomycin hydrochloride	Alvogen Inc.	ANDA	Current
51991-940	Vancomycin Hydrochloride	Vancomycin	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-940	Vancomycin Hydrochloride	Vancomycin	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-941	Vancomycin Hydrochloride	Vancomycin	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-941	Vancomycin Hydrochloride	Vancomycin	Breckenridge Pharmaceutical, Inc.	ANDA	Current
68001-338	Vancomycin Hydrochloride	Vancomycin	BluePoint Laboratories	ANDA	Current
68001-338	Vancomycin Hydrochloride	Vancomycin	BluePoint Laboratories	ANDA	Current
68001-339	Vancomycin Hydrochloride	Vancomycin	BluePoint Laboratories	ANDA	Current
68001-339	Vancomycin Hydrochloride	Vancomycin	BluePoint Laboratories	ANDA	Current
68083-143	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Gland Pharma Limited	ANDA	Current
68083-143	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Gland Pharma Limited	ANDA	Current
68083-144	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Gland Pharma Limited	ANDA	Current
68083-144	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Gland Pharma Limited	ANDA	Current
70860-104	Vancomycin Hydrochloride	vancomycin hydrochloride	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-105	Vancomycin Hydrochloride	vancomycin hydrochloride	Athenex Pharmaceutical Division, LLC.	ANDA	Current
72611-761	Vancomycin Hydrochloride	vancomycin hydrochloride	Almaject, Inc.	ANDA	Current
72611-761	Vancomycin Hydrochloride	vancomycin hydrochloride	Almaject, Inc.	ANDA	Current
72611-761	Vancomycin Hydrochloride	vancomycin hydrochloride	Almaject, Inc.	ANDA	Current
72611-765	Vancomycin Hydrochloride	vancomycin hydrochloride	Almaject, Inc.	ANDA	Current
72611-765	Vancomycin Hydrochloride	vancomycin hydrochloride	Almaject, Inc.	ANDA	Current
72611-765	Vancomycin Hydrochloride	vancomycin hydrochloride	Almaject, Inc.	ANDA	Current