Application 050780

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	CEFUROXIME SODIUM	INJECTABLE;INJECTION	EQ 750MG BASE/VIAL	Yes	Yes
002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	CEFUROXIME SODIUM	INJECTABLE;INJECTION	EQ 1.5GM BASE/VIAL	Yes	Yes

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
N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	CEFUROXIME SODIUM	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION		RLD	2001-02-21
N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	CEFUROXIME SODIUM	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION		RLD	2001-02-21

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	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION		RLD	2001-02-21	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION		RLD	2001-02-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION		RLD	2001-02-21	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION		RLD	2001-02-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION		RLD	2001-02-21	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION		RLD	2001-02-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION		RLD	2001-02-21	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION		RLD	2001-02-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION		RLD	2001-02-21	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION		RLD	2001-02-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION		RLD	2001-02-21	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION		RLD	2001-02-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION		RLD, RS	2001-02-21	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050780-001	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050780-002	CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER	EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2001-02-21	`3a93d1ddd44b…`

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	N050780-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050780-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050780-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050780-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050780-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050780-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050780-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050780-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050780-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050780-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050780-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050780-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050780-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050780-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050780-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050780-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050780-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050780-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050780-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050780-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050780-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050780-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050780-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050780-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050780-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050780-002	AP	1	`ea99ee380514…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050780-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050780-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050780-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050780-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050780-002	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050780-001	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050780-002	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050780-001	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050780-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050780-001	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050780-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050780-001	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050780-002	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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefuroxime and Dextrose	CEFUROXIME AND DEXTROSE	B. Braun Medical Inc.	07170ee3-1a24-424f-a2a2-00bc92e98f85	2020-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050780 application number: NDA050780 ndc (product): 0264-3112 ndc (product): 0264-3114

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0264-3112	Cefuroxime and Dextrose	CEFUROXIME AND DEXTROSE	B. Braun Medical Inc.	NDA	Current
0264-3112	Cefuroxime and Dextrose	CEFUROXIME AND DEXTROSE	B. Braun Medical Inc.	NDA	Current
0264-3114	Cefuroxime and Dextrose	CEFUROXIME AND DEXTROSE	B. Braun Medical Inc.	NDA	Current
0264-3114	Cefuroxime and Dextrose	CEFUROXIME AND DEXTROSE	B. Braun Medical Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65550	SUPPL	2020-12-09
65523	SUPPL	2020-12-08
39322	SUPPL	2015-05-04
30528	SUPPL	2015-05-04
18233	SUPPL	2007-09-11
8273	SUPPL	2007-09-11
30527	SUPPL	2005-05-17
30526	SUPPL	2004-07-01
8272	SUPPL	2003-08-29
42733	ORIG	2001-02-21
18232	ORIG	2001-02-21
8271	ORIG	2001-02-21