Application 207131

Type: NDA
Sponsor: BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFAZOLIN IN PLASTIC CONTAINER	CEFAZOLIN SODIUM	SOLUTION;INTRAVENOUS	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	No	No
002	CEFAZOLIN IN PLASTIC CONTAINER	CEFAZOLIN SODIUM	SOLUTION;INTRAVENOUS	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	Yes	Yes
003	CEFAZOLIN IN DEXTROSE	CEFAZOLIN SODIUM	SOLUTION;INTRAVENOUS	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N207131-001	CEFAZOLIN IN DEXTROSE	CEFAZOLIN SODIUM	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07
N207131-002	CEFAZOLIN IN DEXTROSE	CEFAZOLIN SODIUM	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01
N207131-003	CEFAZOLIN IN DEXTROSE	CEFAZOLIN SODIUM	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-05-31

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 2 of 3 · 98 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207131-002	CEFAZOLIN IN DEXTROSE	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207131-003	CEFAZOLIN IN DEXTROSE	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207131-001	CEFAZOLIN IN DEXTROSE	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207131-002	CEFAZOLIN IN DEXTROSE	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207131-003	CEFAZOLIN IN DEXTROSE	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207131-001	CEFAZOLIN IN DEXTROSE	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207131-002	CEFAZOLIN IN DEXTROSE	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207131-003	CEFAZOLIN IN DEXTROSE	EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207131-002	CEFAZOLIN IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207131-002	CEFAZOLIN IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207131-002	CEFAZOLIN IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207131-002	CEFAZOLIN IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-08-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207131-002	CEFAZOLIN IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207131-002	CEFAZOLIN IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207131-002	CEFAZOLIN IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-08-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-08-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-08-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-08-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-08-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS		2015-08-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207131-002	CEFAZOLIN IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N207131-002	CEFAZOLIN IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N207131-002	CEFAZOLIN IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207131-002	CEFAZOLIN IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207131-002	CEFAZOLIN IN PLASTIC CONTAINER	EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2021-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207131-001	CEFAZOLIN IN PLASTIC CONTAINER	EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2015-08-07	`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 · 5 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	Name fallback generic name: CEFAZOLIN SODIUM
CEFAZOLIN	CEFAZOLIN SODIUM	Samson Medical Technologies, L.L.C.	cf13db9c-d8a1-489f-9aa0-fc70839d4bbc	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: CEFAZOLIN SODIUM
Cefazolin Sodium	CEFAZOLIN SODIUM	Direct_rx	22dfc2e4-07a7-8d13-e063-6394a90a3e9f	2024-09-24	Warnings, Adverse reactions	Name fallback generic name: CEFAZOLIN SODIUM
CEFAZOLIN	CEFAZOLIN SODIUM	Fresenius Kabi USA, LLC	c47c8d14-1eef-40f9-9d11-f0c300b1d4be	2023-09-27	Warnings, Adverse reactions	Name fallback generic name: CEFAZOLIN SODIUM
Cefazolin	CEFAZOLIN SODIUM	Fresenius Kabi USA, LLC	47a8928f-708d-418a-829b-36eded96bac0	2020-06-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CEFAZOLIN SODIUM

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-3503	Cefazolin	Cefazolin Sodium	Baxter Healthcare Corporation	NDA	Current
0338-3503	Cefazolin	Cefazolin Sodium	Baxter Healthcare Corporation	NDA	Current
0338-3503	Cefazolin	Cefazolin Sodium	Baxter Healthcare Corporation	NDA	Current
0338-3508	Cefazolin	Cefazolin Sodium	Baxter Healthcare Corporation	NDA	Current
0338-3508	Cefazolin	Cefazolin Sodium	Baxter Healthcare Corporation	NDA	Current
0338-3508	Cefazolin	Cefazolin Sodium	Baxter Healthcare Corporation	NDA	Current
0338-3508	Cefazolin	Cefazolin Sodium	Baxter Healthcare Corporation	NDA	Current
0338-3508	Cefazolin	Cefazolin Sodium	Baxter Healthcare Corporation	NDA	Current
0338-3508	Cefazolin	Cefazolin Sodium	Baxter Healthcare Corporation	NDA	Current
0338-3508	Cefazolin	Cefazolin Sodium	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78620	SUPPL	2024-06-04
78613	SUPPL	2024-06-03
77385	SUPPL	2024-02-02
73525	SUPPL	2024-02-02
68671	SUPPL	2021-09-21
66115	SUPPL	2021-02-05
66074	SUPPL	2021-02-03
47279	SUPPL	2017-02-22
45551	SUPPL	2016-10-14
24525	ORIG	2016-04-13
23032	ORIG	2016-04-13
19958	ORIG	2015-09-09
32847	ORIG	2015-08-24