Application 065241

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	No	No
002	AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL;EQ 1GM BASE/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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065241-001	AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP		2006-07-25
A065241-002	AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP		2006-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065241-001	AP
A065241-002	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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A065241-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A065241-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A065241-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065241-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065241-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065241-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065241-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065241-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065241-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065241-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065241-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065241-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065241-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065241-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065241-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065241-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065241-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065241-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065241-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065241-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065241-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065241-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065241-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065241-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065241-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065241-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065241-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065241-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065241-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065241-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065241-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065241-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065241-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065241-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065241-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065241-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065241-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065241-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065241-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065241-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-07-25	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A065241-001	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A065241-002	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A065241-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065241-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065241-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065241-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065241-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065241-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065241-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065241-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065241-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065241-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065241-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065241-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065241-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065241-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065241-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065241-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065241-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065241-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065241-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065241-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065241-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065241-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065241-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065241-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065241-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065241-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065241-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065241-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065241-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065241-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065241-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065241-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065241-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065241-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065241-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065241-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065241-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065241-002	AP	1	`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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ampicillin and Sulbactam	AMPICILLIN SODIUM AND SULBACTAM SODIUM	Meitheal Pharmaceuticals Inc.	139b4b2e-46f7-44a8-9cc1-774afa463b80	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Ampicillin and Sulbactam
Ampicillin and Sulbactam	AMPICILLIN SODIUM AND SULBACTAM SODIUM	Meitheal Pharmaceuticals Inc.	006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d	2026-07-22	Warnings, Adverse reactions	Name fallback brand name: Ampicillin and Sulbactam
Ampicillin and Sulbactam	AMPICILLIN AND SULBACTAM	WG Critical Care, LLC	72a37674-8cb2-4b40-aac8-d345ffcf22f2	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Ampicillin and Sulbactam
Ampicillin and Sulbactam	AMPICILLIN AND SULBACTAM	WG Critical Care, LLC	9a722de6-9dc0-4fb9-b63a-225385aa3314	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Ampicillin and Sulbactam
Ampicillin and Sulbactam	AMPICILLIN AND SULBACTAM	WG Critical Care, LLC	77158167-0c1e-4f01-a5b0-a3df8ad121f5	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ampicillin and Sulbactam
Ampicillin and Sulbactam	AMPICILLIN SODIUM AND SULBACTAM SODIUM	Meitheal Pharmaceuticals Inc.	e6cf14a8-3ed9-4a7a-ba69-be0b794cbdc4	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Ampicillin and Sulbactam
Ampicillin and Sulbactam	AMPICILLIN SODIUM AND SULBACTAM SODIUM	Medical Purchasing Solutions, LLC.	4e81c215-2ab6-87c6-e063-6294a90ac28c	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: Ampicillin and Sulbactam
Ampicillin and Sulbactam	AMPICILLIN AND SULBACTAM	Hikma Pharmaceuticals USA Inc.	a65a70bf-4283-4bc0-b576-00c9ab29bd64	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Ampicillin and Sulbactam
Ampicillin and Sulbactam	AMPICILLIN AND SULBACTAM	Hikma Pharmaceuticals USA Inc.	d3026cc0-95d8-44cf-be47-b5ebb8fd4568	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Ampicillin and Sulbactam
Ampicillin and Sulbactam	AMPICILLIN SODIUM AND SULBACTAM SODIUM	Hospira, Inc	dc374fa4-350b-425d-a7db-7099fdc64cf1	2026-01-21	Warnings, Adverse reactions	Name fallback brand name: Ampicillin and Sulbactam
Ampicillin and Sulbactam	AMPICILLIN SODIUM AND SULBACTAM SODIUM	Eugia US LLC	437a26f4-776b-4f74-99b2-09ad79831b0c	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Ampicillin and Sulbactam
Ampicillin and Sulbactam	AMPICILLIN SODIUM AND SULBACTAM SODIUM	Eugia US LLC	16fdfdb9-9e26-48d0-8838-570d30c8e897	2025-11-04	Warnings, Adverse reactions	Name fallback brand name: Ampicillin and Sulbactam
Ampicillin and Sulbactam	AMPICILLIN SODIUM AND SULBACTAM SODIUM	Eugia US LLC	adc92303-b62b-41c8-becf-9c3a4e8c3a6b	2025-08-12	Warnings, Adverse reactions	Name fallback brand name: Ampicillin and Sulbactam
Ampicillin and Sulbactam	AMPICILLIN SODIUM AND SULBACTAM SODIUM	Eugia US LLC	2709e9fc-2341-4382-af72-c2e3201bd77a	2025-08-12	Warnings, Adverse reactions	Name fallback brand name: Ampicillin and Sulbactam
Ampicillin and Sulbactam	AMPICILLIN SODIUM AND SULBACTAM SODIUM	Meitheal Pharmaceuticals Inc.	9f2ff165-2a21-4155-a4f0-57885a83c7dc	2025-07-24	Warnings, Adverse reactions	Name fallback brand name: Ampicillin and Sulbactam
Ampicillin and Sulbactam	AMPICILLIN AND SULBACTAM	Avenacy, LLC	577dd6f0-d56a-4c82-9f72-274c3a4a0f01	2025-04-25	Warnings, Adverse reactions	Name fallback brand name: Ampicillin and Sulbactam
Ampicillin and Sulbactam	AMPICILLIN AND SULBACTAM	Avenacy, LLC	4446d4c8-056d-4bc3-8f58-21255b063398	2025-04-25	Warnings, Adverse reactions	Name fallback brand name: Ampicillin and Sulbactam
ampicillin and sulbactam	AMPICILLIN AND SULBACTAM	Sagent Pharmaceuticals	35606b43-5914-423c-9bc7-fa3957eb2563	2024-11-18	Warnings, Adverse reactions	Name fallback brand name: ampicillin and sulbactam
Ampicillin and Sulbactam	AMPICILLIN SODIUM AND SULBACTAM SODIUM	NorthStar Rx, LLC	5e8d35cb-e93d-42ad-a02c-0dbf04910f61	2024-08-13	Warnings, Adverse reactions	Name fallback brand name: Ampicillin and Sulbactam
Ampicillin and Sulbactam	AMPICILLIN SODIUM AND SULBACTAM SODIUM	NorthStar Rx, LLC	1e5004f1-e79e-4e0b-9f3f-25f6bbc15255	2024-06-27	Warnings, Adverse reactions	Name fallback brand name: Ampicillin and Sulbactam

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-3032	Ampicillin and Sulbactam	Ampicillin sodium and Sulbactam sodium	Sandoz Inc	ANDA	Current
0781-3032	Ampicillin and Sulbactam	Ampicillin sodium and Sulbactam sodium	Sandoz Inc	ANDA	Current
0781-3032	Ampicillin and Sulbactam	Ampicillin sodium and Sulbactam sodium	Sandoz Inc	ANDA	Current
0781-3032	Ampicillin and Sulbactam	Ampicillin sodium and Sulbactam sodium	Sandoz Inc	ANDA	Current
0781-3033	Ampicillin and Sulbactam	Ampicillin sodium and Sulbactam sodium	Sandoz Inc	ANDA	Current
0781-3033	Ampicillin and Sulbactam	Ampicillin sodium and Sulbactam sodium	Sandoz Inc	ANDA	Current
0781-3033	Ampicillin and Sulbactam	Ampicillin sodium and Sulbactam sodium	Sandoz Inc	ANDA	Current
0781-3033	Ampicillin and Sulbactam	Ampicillin sodium and Sulbactam sodium	Sandoz Inc	ANDA	Current