Application 050646

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEPTAZ	CEFTAZIDIME	INJECTABLE;INJECTION	500MG/VIAL	No	No
002	CEPTAZ	CEFTAZIDIME	INJECTABLE;INJECTION	1GM/VIAL	No	No
003	CEPTAZ	CEFTAZIDIME	INJECTABLE;INJECTION	2GM/VIAL	No	No
004	CEPTAZ	CEFTAZIDIME	INJECTABLE;INJECTION	10GM/VIAL	No	No

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	Approval date
N050646-001	CEPTAZ	CEFTAZIDIME	500MG/VIAL	INJECTABLE / INJECTION	1990-09-27
N050646-002	CEPTAZ	CEFTAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1990-09-27
N050646-003	CEPTAZ	CEFTAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1990-09-27
N050646-004	CEPTAZ	CEFTAZIDIME	10GM/VIAL	INJECTABLE / INJECTION	1990-09-27

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 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050646-001	CEPTAZ	500MG/VIAL	INJECTABLE / INJECTION	1990-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050646-002	CEPTAZ	1GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050646-003	CEPTAZ	2GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050646-004	CEPTAZ	10GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050646-001	CEPTAZ	500MG/VIAL	INJECTABLE / INJECTION	1990-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050646-002	CEPTAZ	1GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050646-003	CEPTAZ	2GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050646-004	CEPTAZ	10GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050646-001	CEPTAZ	500MG/VIAL	INJECTABLE / INJECTION	1990-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050646-002	CEPTAZ	1GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050646-003	CEPTAZ	2GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050646-004	CEPTAZ	10GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050646-001	CEPTAZ	500MG/VIAL	INJECTABLE / INJECTION	1990-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050646-002	CEPTAZ	1GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050646-003	CEPTAZ	2GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050646-004	CEPTAZ	10GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050646-001	CEPTAZ	500MG/VIAL	INJECTABLE / INJECTION	1990-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050646-002	CEPTAZ	1GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050646-003	CEPTAZ	2GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050646-004	CEPTAZ	10GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050646-001	CEPTAZ	500MG/VIAL	INJECTABLE / INJECTION	1990-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050646-002	CEPTAZ	1GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050646-003	CEPTAZ	2GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050646-004	CEPTAZ	10GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050646-001	CEPTAZ	500MG/VIAL	INJECTABLE / INJECTION	1990-09-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050646-002	CEPTAZ	1GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050646-003	CEPTAZ	2GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050646-004	CEPTAZ	10GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050646-001	CEPTAZ	500MG/VIAL	INJECTABLE / INJECTION	1990-09-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050646-002	CEPTAZ	1GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050646-003	CEPTAZ	2GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050646-004	CEPTAZ	10GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050646-001	CEPTAZ	500MG/VIAL	INJECTABLE / INJECTION	1990-09-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050646-002	CEPTAZ	1GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050646-003	CEPTAZ	2GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050646-004	CEPTAZ	10GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050646-001	CEPTAZ	500MG/VIAL	INJECTABLE / INJECTION	1990-09-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050646-002	CEPTAZ	1GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050646-003	CEPTAZ	2GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050646-004	CEPTAZ	10GM/VIAL	INJECTABLE / INJECTION	1990-09-27	`4b0b4de00fa7…`

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
Ceftazidime	CEFTAZIDIME	Sagent Pharmaceuticals	112c5457-8d71-49f5-b531-9761d7d38c93	2026-08-03	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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30219	SUPPL	2002-03-29
17971	SUPPL	2002-03-29