Application 061667

Type: ANDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VANCOCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	FOR SOLUTION;ORAL	EQ 500MG BASE/6ML	No	No
002	VANCOCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	FOR SOLUTION;ORAL	EQ 250MG BASE/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A061667-001	VANCOCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982
A061667-002	VANCOCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS	1983-07-13

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL			1983-07-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS	1983-07-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS	1983-07-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS	1983-07-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS	1983-07-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS	1983-07-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS	1983-07-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL			1983-07-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL			1983-07-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL			1983-07-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS	1983-07-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS	1983-07-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS	1983-07-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS	1983-07-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS	1983-07-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS	1983-07-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS	1983-07-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS	1983-07-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS	1983-07-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS	1983-07-13	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061667-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061667-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061667-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061667-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061667-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061667-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061667-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061667-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061667-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061667-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061667-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061667-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061667-002	AA	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A061667-002	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A061667-002	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A061667-002	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A061667-002	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A061667-002	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A061667-002	AA	1	`a67488948f0b…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	28fe3c01-cf87-41c0-87fd-f93a40524335	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061667 application number: ANDA061667
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	6c74b360-022a-4c4d-9e4b-0988219a78fb	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061667 application number: ANDA061667
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	8193f588-a032-451e-a0a1-819a5ea834c8	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061667 application number: ANDA061667
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	a09c589b-e7f4-457c-827f-e1bfa1b26700	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061667 application number: ANDA061667 ndc (product): 63629-1972
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	786bde33-9aec-4b4d-ba46-90bfd61956d0	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061667 application number: ANDA061667 ndc (product): 63629-1970
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	9b6a7a21-4fde-40c6-a420-a8546a4dc701	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061667 application number: ANDA061667 ndc (product): 63629-1971
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	27d06545-1af0-4dcd-926d-58d4a9492ec3	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061667 application number: ANDA061667 ndc (product): 62559-830

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62559-830	Vancomycin Hydrochloride	Vancomycin Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-830	Vancomycin Hydrochloride	Vancomycin Hydrochloride	ANI Pharmaceuticals, Inc.	ANDA	Current
63629-1970	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1970	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1970	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1970	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1970	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1971	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1971	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1971	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1971	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1972	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1972	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1972	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1972	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62197	SUPPL	2020-03-19
22255	ORIG	2012-10-12