Application 217409

Type: ANDA
Sponsor: EUGIA PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	INJECTABLE;INJECTION	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	No	No
002	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	INJECTABLE;INJECTION	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	No	No
003	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN,TAZOBACTAM	INJECTION;POWDER,FOR SOLUTION	0.375G	No	No
004	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN,TAZOBACTAM	INJECTION;POWDER,FOR SOLUTION	3.0G	No	No
005	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN,TAZOBACTAM	INJECTION;POWDER,FOR SOLUTION	0.5G/1VIAL	No	No
006	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN,TAZOBACTAM	INJECTION;POWDER,FOR SOLUTION	4.0G	No	No
007	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN,TAZOBACTAM	INJECTION;POWDER,FOR SOLUTION	4.5G	No	No
008	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN,TAZOBACTAM	INJECTION;POWDER,FOR SOLUTION	36G	No	No
009	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN,TAZOBACTAM	INJECTION;POWDER,FOR SOLUTION	EQ 12GM BASE/VIAL;EQ 1.5GMBASE/VIAL	No	No
010	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN,TAZOBACTAM	INJECTION;POWDER,FOR SOLUTION	EQ 36GM BASE/VIAL;EQ 4.5GMBASE/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
A217409-001	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12
A217409-002	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217409-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217409-002	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217409-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217409-002	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217409-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217409-002	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217409-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217409-002	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217409-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217409-002	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217409-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217409-002	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217409-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217409-002	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217409-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217409-002	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217409-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217409-002	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217409-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217409-002	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217409-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217409-002	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217409-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217409-002	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217409-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217409-002	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217409-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217409-002	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217409-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217409-002	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217409-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217409-002	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION			2023-10-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217409-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2023-10-12	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217409-002	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2023-10-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217409-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2023-10-12	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217409-002	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2023-10-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217409-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2023-10-12	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217409-002	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2023-10-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217409-001	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2023-10-12	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217409-002	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION		RS	2023-10-12	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217409-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217409-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217409-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217409-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217409-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217409-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217409-001	AP	1	`a72a2bbeb626…`

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
Piperacillin and Tazobactam	PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM	Eugia US LLC	80f4bdb8-131e-4485-b7a2-accd596d4cde	2024-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217409 application number: ANDA217409