Application 050779

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFAZOLIN AND DEXTROSE	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	No	No
002	CEFAZOLIN AND DEXTROSE	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	Yes	Yes
003	CEFAZOLIN AND DEXTROSE	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	Yes	No
004	CEFAZOLIN AND DEXTROSE	CEFAZOLIN SODIUM	INJECTABLE;INJECTION	EQ 3GM 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N050779-001	CEFAZOLIN AND DEXTROSE	CEFAZOLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2000-07-27
N050779-002	CEFAZOLIN AND DEXTROSE	CEFAZOLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-07-27
N050779-003	CEFAZOLIN AND DEXTROSE	CEFAZOLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2012-01-13
N050779-004	CEFAZOLIN AND DEXTROSE	CEFAZOLIN SODIUM	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2024-08-26

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 4 of 4 · 142 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2023-05-13 08:27 UTC	2023-05	N050779-001	CEFAZOLIN AND DEXTROSE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2000-07-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050779-002	CEFAZOLIN AND DEXTROSE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-07-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050779-003	CEFAZOLIN AND DEXTROSE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2012-01-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050779-001	CEFAZOLIN AND DEXTROSE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2000-07-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050779-002	CEFAZOLIN AND DEXTROSE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-07-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050779-003	CEFAZOLIN AND DEXTROSE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2012-01-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050779-001	CEFAZOLIN AND DEXTROSE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2000-07-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050779-002	CEFAZOLIN AND DEXTROSE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-07-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050779-003	CEFAZOLIN AND DEXTROSE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2012-01-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050779-001	CEFAZOLIN AND DEXTROSE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2000-07-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050779-002	CEFAZOLIN AND DEXTROSE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-07-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050779-003	CEFAZOLIN AND DEXTROSE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2012-01-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050779-001	CEFAZOLIN AND DEXTROSE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2000-07-27	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050779-002	CEFAZOLIN AND DEXTROSE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-07-27	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050779-003	CEFAZOLIN AND DEXTROSE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2012-01-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050779-001	CEFAZOLIN AND DEXTROSE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2000-07-27	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050779-002	CEFAZOLIN AND DEXTROSE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-07-27	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050779-003	CEFAZOLIN AND DEXTROSE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2012-01-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050779-001	CEFAZOLIN AND DEXTROSE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2000-07-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050779-002	CEFAZOLIN AND DEXTROSE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2000-07-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050779-003	CEFAZOLIN AND DEXTROSE	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2012-01-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050779-004	CEFAZOLIN AND DEXTROSE	EQ 3GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2024-08-26	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-12-20 04:57 UTC	2023-12	N050779-001	NPP	2023-11-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050779-002	NPP	2023-11-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050779-003	NPP	2023-11-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050779-001	NPP	2023-11-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050779-002	NPP	2023-11-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050779-003	NPP	2023-11-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050779-001	NPP	2023-11-23	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050779-002	NPP	2023-11-23	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050779-003	NPP	2023-11-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050779-001	NPP	2023-11-23	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050779-002	NPP	2023-11-23	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050779-003	NPP	2023-11-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050779-001	NPP	2023-11-23	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050779-002	NPP	2023-11-23	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050779-003	NPP	2023-11-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050779-001	NPP	2023-11-23	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050779-002	NPP	2023-11-23	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050779-003	NPP	2023-11-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050779-001	NPP	2023-11-23	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050779-002	NPP	2023-11-23	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050779-003	NPP	2023-11-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050779-001	NPP	2023-11-23	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050779-002	NPP	2023-11-23	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050779-003	NPP	2023-11-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050779-001	NPP	2023-11-23	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050779-002	NPP	2023-11-23	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050779-003	NPP	2023-11-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050779-001	NPP	2023-11-23	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050779-002	NPP	2023-11-23	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050779-003	NPP	2023-11-23	`e64feba35796…`

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
Cefazolin Sodium	CEFAZOLIN SODIUM	B. Braun Medical Inc.	17f8f038-c204-4dab-80d7-6f7ac41ddbec	2025-03-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050779 application number: NDA050779 ndc (product): 0264-3103 ndc (product): 0264-3105

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0264-3103	Cefazolin Sodium	Cefazolin Sodium	B. Braun Medical Inc.	NDA	Current
0264-3103	Cefazolin Sodium	Cefazolin Sodium	B. Braun Medical Inc.	NDA	Current
0264-3103	Cefazolin Sodium	Cefazolin Sodium	B. Braun Medical Inc.	NDA	Current
0264-3105	Cefazolin Sodium	Cefazolin Sodium	B. Braun Medical Inc.	NDA	Current
0264-3105	Cefazolin Sodium	Cefazolin Sodium	B. Braun Medical Inc.	NDA	Current
0264-3105	Cefazolin Sodium	Cefazolin Sodium	B. Braun Medical Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80901	SUPPL	2025-02-04
79510	SUPPL	2024-09-02
79485	SUPPL	2024-08-27
68975	SUPPL	2021-10-13
68962	SUPPL	2021-10-12
65344	SUPPL	2020-11-25
65328	SUPPL	2020-11-25
64234	SUPPL	2020-08-07
39321	SUPPL	2015-10-15
30525	SUPPL	2015-10-13
30524	SUPPL	2014-09-23
30523	SUPPL	2012-04-25
39320	SUPPL	2012-04-23
18231	SUPPL	2012-01-26
30522	SUPPL	2012-01-18
8269	SUPPL	2008-11-07
42732	SUPPL	2007-09-24
39319	SUPPL	2007-09-11
8270	SUPPL	2007-09-11
30521	SUPPL	2005-05-17
39318	SUPPL	2004-07-01
8268	SUPPL	2004-07-01
22235	ORIG	2000-08-04
18230	ORIG	2000-08-04
8267	ORIG	2000-08-04