Application 065430

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	CEFOTETAN DISODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	Yes	Yes
002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	CEFOTETAN DISODIUM	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	CEFOTETAN DISODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		RLD	2007-08-09
N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	CEFOTETAN DISODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION		RLD	2007-08-09

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 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD	2007-08-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2007-08-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2007-08-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2007-08-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2007-08-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2007-08-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2007-08-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2007-08-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2007-08-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2007-08-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2007-08-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N065430-001	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2007-08-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N065430-002	CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	RLD, RS	2007-08-09	`782e0a99824c…`

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
Cefotetan	CEFOTETAN DISODIUM	Fresenius Kabi USA, LLC	bd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: CEFOTETAN DISODIUM

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
0264-3173	Cefotetan and Dextrose	CEFOTETAN and DEXTROSE	B. Braun Medical Inc.	NDA	Current
0264-3173	Cefotetan and Dextrose	CEFOTETAN and DEXTROSE	B. Braun Medical Inc.	NDA	Current
0264-3173	Cefotetan and Dextrose	CEFOTETAN and DEXTROSE	B. Braun Medical Inc.	NDA	Current
0264-3175	Cefotetan and Dextrose	CEFOTETAN and DEXTROSE	B. Braun Medical Inc.	NDA	Current
0264-3175	Cefotetan and Dextrose	CEFOTETAN and DEXTROSE	B. Braun Medical Inc.	NDA	Current
0264-3175	Cefotetan and Dextrose	CEFOTETAN and DEXTROSE	B. Braun Medical Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61745	SUPPL	2020-01-31
61744	SUPPL	2020-01-31
30661	ORIG	2007-08-14