Application 201048

Type: ANDA
Sponsor: SANDOZ INC

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 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
A201048-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION			2012-08-10
A201048-002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION			2012-08-10

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	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A201048-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201048-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201048-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201048-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201048-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201048-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201048-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201048-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201048-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201048-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201048-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201048-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201048-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201048-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201048-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201048-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201048-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201048-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201048-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201048-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201048-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201048-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201048-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A201048-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201048-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A201048-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201048-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201048-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201048-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201048-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201048-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201048-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201048-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201048-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201048-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A201048-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201048-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A201048-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201048-001	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201048-002	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2012-08-10	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

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	A201048-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201048-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201048-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201048-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201048-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201048-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201048-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201048-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201048-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201048-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201048-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201048-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201048-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201048-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201048-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201048-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201048-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201048-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201048-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201048-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201048-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201048-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201048-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201048-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201048-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201048-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201048-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201048-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201048-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A201048-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201048-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A201048-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201048-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201048-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201048-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201048-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201048-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201048-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201048-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201048-002	AP	1	`3f0d92c62455…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Plano Pharmaceuticals Inc.	4983f60c-0f7b-d427-e063-6394a90a838c	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201048 application number: ANDA201048

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.