Application 050823

Type: NDA
Sponsor: B BRAUN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFTAZIDIME IN DEXTROSE CONTAINER	CEFTAZIDIME	INJECTABLE;INJECTION	EQ 1GM BASE	Yes	No
002	CEFTAZIDIME IN DEXTROSE CONTAINER	CEFTAZIDIME	INJECTABLE;INJECTION	EQ 2GM BASE	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
N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	CEFTAZIDIME	EQ 1GM BASE	INJECTABLE / INJECTION		RLD	2011-06-13
N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	CEFTAZIDIME	EQ 2GM BASE	INJECTABLE / INJECTION		RLD	2011-06-13

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	N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 1GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 2GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 1GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 2GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 1GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 2GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 1GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 2GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 1GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 2GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 1GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 2GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 1GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 2GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 1GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 2GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 1GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 2GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 1GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 2GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 1GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 2GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 1GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 2GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 1GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 2GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 1GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 2GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 1GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 2GM BASE	INJECTABLE / INJECTION	RLD, RS	2011-06-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 1GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 2GM BASE	INJECTABLE / INJECTION	RLD, RS	2011-06-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 1GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 2GM BASE	INJECTABLE / INJECTION	RLD, RS	2011-06-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 1GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 2GM BASE	INJECTABLE / INJECTION	RLD, RS	2011-06-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 1GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 2GM BASE	INJECTABLE / INJECTION	RLD, RS	2011-06-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050823-001	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 1GM BASE	INJECTABLE / INJECTION	RLD	2011-06-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050823-002	CEFTAZIDIME IN DEXTROSE CONTAINER	EQ 2GM BASE	INJECTABLE / INJECTION	RLD, RS	2011-06-13	`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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ceftazidime	CEFTAZIDIME	WG Critical Care, LLC	22d6534c-4488-48a1-8d78-e2fb908259de	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CEFTAZIDIME
TAZICEF	CEFTAZIDIME	Hospira, Inc.	9b73979c-c95a-4433-0a9d-f9cea3cb557f	2026-06-04	Warnings, Adverse reactions	Name fallback generic name: CEFTAZIDIME
TAZICEF	CEFTAZIDIME	Hospira, Inc.	40d48c5d-650e-461b-a67b-7e65772d1b92	2026-05-04	Warnings, Adverse reactions	Name fallback generic name: CEFTAZIDIME
TAZICEF	CEFTAZIDIME	Hospira, Inc.	1ab5ae3e-e303-4499-4c89-472d7cc1e46c	2024-07-04	Warnings, Adverse reactions	Name fallback generic name: CEFTAZIDIME
Ceftazidime	CEFTAZIDIME	Sagent Pharmaceuticals	aec64360-8452-4987-a366-a5a4f8762ab6	2024-01-03	Warnings, Adverse reactions	Name fallback generic name: CEFTAZIDIME
Ceftazidime	CEFTAZIDIME	WG Critical Care, LLC	bcc81df2-20e3-4738-bfcf-301da883c1d9	2023-09-11	Warnings, Adverse reactions	Name fallback generic name: CEFTAZIDIME
Ceftazidime	CEFTAZIDIME	Sagent Pharmaceuticals	112c5457-8d71-49f5-b531-9761d7d38c93	2020-10-05	Warnings, Adverse reactions	Name fallback generic name: CEFTAZIDIME

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
0264-3143	Ceftazidime and Dextrose	CEFTAZIDIME	B. Braun Medical Inc.	NDA	Current
0264-3143	Ceftazidime and Dextrose	CEFTAZIDIME	B. Braun Medical Inc.	NDA	Current
0264-3143	Ceftazidime and Dextrose	CEFTAZIDIME	B. Braun Medical Inc.	NDA	Current
0264-3145	Ceftazidime and Dextrose	CEFTAZIDIME	B. Braun Medical Inc.	NDA	Current
0264-3145	Ceftazidime and Dextrose	CEFTAZIDIME	B. Braun Medical Inc.	NDA	Current
0264-3145	Ceftazidime and Dextrose	CEFTAZIDIME	B. Braun Medical Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69079	SUPPL	2021-10-25
69053	SUPPL	2021-10-21
59514	SUPPL	2019-07-30
59506	SUPPL	2019-07-30
39392	SUPPL	2015-05-21
8343	SUPPL	2015-05-19
42756	ORIG	2012-06-05
24351	ORIG	2012-06-05
8342	ORIG	2011-06-27