Application 202274

Type: ANDA
Sponsor: EMCURE PHARMS LTD

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202274-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION			2013-10-31

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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2013-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202274-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION		2013-10-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A202274-001	AP	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A202274-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202274-001	AP	1	`ea99ee380514…`

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 4 · 75 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
vancomycin hydrochloride	VANCOMYCIN HYDROCHLORIDE	Redpharm Drug	57d23aed-a3f7-f92e-e063-6394a90add7d	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: vancomycin hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hospira, Inc.	b01aaa02-8f1d-4b57-96a5-337503428af1	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
FIRVANQ	VANCOMYCIN HYDROCHLORIDE	Azurity Pharmaceuticals, Inc	5aca5508-b577-446c-9980-ab4c7582b4b9	2026-07-14	Warnings, Adverse reactions	Name fallback generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride for Oral Solution	VANCOMYCIN HYDROCHLORIDE	Wilshire Pharmaceuticals, Inc.	4c3d2e99-5351-4442-916a-d2001b0a5f5a	2026-07-14	Warnings, Adverse reactions	Name fallback generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Meitheal Pharmaceuticals Inc.	033efc76-11d5-4a93-91de-56ed41bab9c3	2026-07-08	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	7bbd2c81-33d9-4397-8795-8b9fa28cb5cf	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	d6b8147b-5f93-49ee-8b27-78fe58987c90	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	28fe3c01-cf87-41c0-87fd-f93a40524335	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Eurofarma, Inc.	826510bd-b611-42d9-a574-ec7ee4151ef5	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	6c74b360-022a-4c4d-9e4b-0988219a78fb	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	8193f588-a032-451e-a0a1-819a5ea834c8	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	99e523d8-9bde-43cb-8434-497015e5dcbd	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: VANCOMYCIN HYDROCHLORIDE generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	a09c589b-e7f4-457c-827f-e1bfa1b26700	2026-05-26	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	786bde33-9aec-4b4d-ba46-90bfd61956d0	2026-05-26	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	9b6a7a21-4fde-40c6-a420-a8546a4dc701	2026-05-26	Warnings, Adverse reactions	Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Slate Run Pharmaceuticals, LLC	6ea38b4d-a6d2-4826-8110-ae42c9f7a42a	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: VANCOMYCIN HYDROCHLORIDE generic name: VANCOMYCIN HYDROCHLORIDE
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	Cameron Pharmaceuticals	bc737938-ae36-460b-a2a8-609f3fe59156	2026-04-14	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

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
23155-219	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-219	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Heritage Pharmaceuticals Inc.	ANDA	Current