Application 062655

Type: ANDA
Sponsor: LILLY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TAZIDIME	CEFTAZIDIME	INJECTABLE;INJECTION	1GM/VIAL	No	No
002	TAZIDIME	CEFTAZIDIME	INJECTABLE;INJECTION	2GM/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A062655-001	TAZIDIME	CEFTAZIDIME	1GM/VIAL	INJECTABLE / INJECTION			1985-11-20
A062655-002	TAZIDIME	CEFTAZIDIME	2GM/VIAL	INJECTABLE / INJECTION			1985-11-20

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A062655-001	TAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062655-002	TAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062655-001	TAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062655-002	TAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062655-001	TAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062655-002	TAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062655-001	TAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A062655-002	TAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062655-001	TAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A062655-002	TAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062655-001	TAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A062655-002	TAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062655-001	TAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A062655-002	TAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062655-001	TAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A062655-002	TAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062655-001	TAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A062655-002	TAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062655-001	TAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062655-002	TAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062655-001	TAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A062655-002	TAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062655-001	TAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A062655-002	TAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062655-001	TAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062655-002	TAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062655-001	TAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062655-002	TAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062655-001	TAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062655-002	TAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062655-001	TAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062655-002	TAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062655-001	TAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A062655-002	TAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062655-001	TAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A062655-002	TAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062655-001	TAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062655-002	TAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062655-001	TAZIDIME	1GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A062655-002	TAZIDIME	2GM/VIAL	INJECTABLE / INJECTION	1985-11-20	`f41ea6bd6efb…`

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.