Application 203557

Type: ANDA
Sponsor: SANDOZ INC

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 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	No	No
002	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	INJECTABLE;INJECTION	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/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
A203557-001	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29
A203557-002	PIPERACILLIN AND TAZOBACTAM	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A203557-001	AP
A203557-002	AP

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 · 78 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	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	2014-10-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2014-10-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2014-10-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2014-10-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203557-002	PIPERACILLIN AND TAZOBACTAM	EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2021-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2014-10-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203557-001	PIPERACILLIN AND TAZOBACTAM	EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2014-10-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203557-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203557-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203557-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203557-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203557-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203557-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203557-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203557-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203557-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203557-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203557-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203557-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203557-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203557-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203557-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203557-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203557-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203557-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203557-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203557-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203557-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203557-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203557-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203557-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203557-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203557-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203557-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203557-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203557-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203557-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203557-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203557-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203557-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203557-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203557-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203557-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203557-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203557-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203557-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203557-001	AP	1	`bb7c543d1eb4…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Piperacillin and Tazobactam	PIPERACILLIN AND TAZOBACTAM	Sandoz Inc	b1cb1314-d3e0-4b44-a1df-de14c32e8cc6	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203557 application number: ANDA203557 ndc (product): 0781-3117 ndc (product): 0781-3180
Piperacillin and Tazobactam	PIPERACILLIN AND TAZOBACTAM	Hospira, Inc	5e8bbfcd-3618-43ed-a158-9d524426fdc5	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203557 application number: ANDA203557 ndc (product): 0409-2999

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-2999	Piperacillin and Tazobactam	Piperacillin and Tazobactam	Hospira, Inc	ANDA	Current
0409-2999	Piperacillin and Tazobactam	Piperacillin and Tazobactam	Hospira, Inc	ANDA	Current
0409-2999	Piperacillin and Tazobactam	Piperacillin and Tazobactam	Hospira, Inc	ANDA	Current
0409-2999	Piperacillin and Tazobactam	Piperacillin and Tazobactam	Hospira, Inc	ANDA	Current
0409-2999	Piperacillin and Tazobactam	Piperacillin and Tazobactam	Hospira, Inc	ANDA	Current
0781-3117	Piperacillin and Tazobactam	Piperacillin and Tazobactam	Sandoz Inc	ANDA	Current
0781-3117	Piperacillin and Tazobactam	Piperacillin and Tazobactam	Sandoz Inc	ANDA	Current
0781-3180	Piperacillin and Tazobactam	Piperacillin and Tazobactam	Sandoz Inc	ANDA	Current
0781-3180	Piperacillin and Tazobactam	Piperacillin and Tazobactam	Sandoz Inc	ANDA	Current
43858-153	Piperacillin and Tazobactam	Piperacillin and Tazobactam	Sandoz GmbH	ANDA	Current