Application 213059

Type: ANDA
Sponsor: KNACK

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 750MG BASE/VIAL	No	No
003	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1GM 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A213059-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15
A213059-002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15
A213059-003	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2022-02-15

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 · 99 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	A213059-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213059-002	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213059-003	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213059-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213059-002	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213059-003	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213059-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213059-002	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213059-003	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213059-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213059-002	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213059-003	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213059-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213059-002	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213059-003	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213059-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213059-002	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213059-003	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213059-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213059-002	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213059-003	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213059-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213059-002	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213059-003	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213059-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213059-002	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213059-003	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213059-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213059-002	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213059-003	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213059-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213059-002	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213059-003	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213059-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213059-002	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213059-003	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213059-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213059-002	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213059-003	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213059-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	2022-02-15	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213059-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213059-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213059-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213059-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213059-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213059-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213059-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213059-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213059-003	AP	1	`4b0b4de00fa7…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213059-001	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213059-002	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213059-003	AP	1	`cb3db0bc1861…`

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 2 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	Slate Run Pharmaceuticals, LLC	57f58371-3ce6-4983-89df-acba33d1139a	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: VANCOMYCIN HYDROCHLORIDE generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	GLENMARK PHARMACEUTICALS INC., USA	74056e26-57fd-448e-af76-edbccfc3efb7	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Civica, Inc	3e041ec6-811b-4f26-9303-959cb09d5f57	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hospira, Inc.	f2901045-904f-47bd-74a1-c561facd7f25	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hospira, Inc.	c9ea31ec-4c26-452f-b07b-c5f894212cd5	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	ae6efaaf-37eb-4510-ba71-5f3dc3abdbd3	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: VANCOMYCIN HYDROCHLORIDE generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Plano Pharmaceuticals Inc.	4983e3c8-e0f2-b366-e063-6394a90a9557	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	27d06545-1af0-4dcd-926d-58d4a9492ec3	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
vancomycin hydrochloride	VANCOMYCIN HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	3707ad2e-5c82-4111-a370-e518e5e7e4c5	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: vancomycin hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Plano Pharmaceuticals Inc.	4983f60c-0f7b-d427-e063-6394a90a838c	2026-02-24	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
vancomycin hydrochloride	VANCOMYCIN HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ab658fbd-68ea-4275-84b1-c3361c860bd3	2026-02-11	Warnings, Adverse reactions	Name fallback brand name: vancomycin hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Gland Pharma Limited	00946db3-d6c5-4534-a870-1ec6e63eda43	2026-01-30	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	XGen Pharmaceuticals DJB, Inc.	4239165c-4c15-b78e-e063-6294a90ae6af	2025-12-31	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	GLENMARK PHARMACEUTICALS INC., USA	0543b2b5-b1c7-4ad6-b38c-3be0086f0e06	2025-12-23	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancocin	VANCOMYCIN HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	a078d9c2-f89c-4f9f-8ded-60ffb2983c3f	2025-12-22	Warnings, Adverse reactions	Name fallback generic name: VANCOMYCIN HYDROCHLORIDE
vancomycin hydrochloride	VANCOMYCIN HYDROCHLORIDE	Redpharm Drug	3745b502-c222-e307-e063-6394a90a697e	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: vancomycin hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
vancomycin hydrochloride	VANCOMYCIN HYDROCHLORIDE	Strides Pharma Science Limited	fac438bd-e08f-438d-ab64-426fc5c5450e	2025-11-28	Warnings, Adverse reactions	Name fallback brand name: vancomycin hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Henry Schein, Inc.	1bda7fa4-fdee-410a-a216-02cfbf91632f	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	STERISCIENCE SPECIALTIES PRIVATE LIMITED	2c355037-6a1e-4846-872a-471ccbdc8d54	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Civica, Inc	50e4fb19-f603-439c-b193-25a455115383	2025-10-13	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.