Application 065406

Type: ANDA
Sponsor: ACS DOBFAR

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 1.

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
A065406-001	AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP		2009-12-22
A065406-002	AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP		2009-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065406-001	AP
A065406-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065406-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065406-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2009-12-22	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065406-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065406-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065406-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065406-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065406-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065406-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065406-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065406-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065406-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065406-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065406-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065406-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065406-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065406-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065406-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065406-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065406-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065406-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065406-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065406-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065406-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065406-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065406-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065406-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065406-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065406-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065406-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065406-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065406-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065406-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065406-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065406-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065406-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065406-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065406-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065406-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065406-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065406-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065406-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065406-002	AP	1	`782e0a99824c…`

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 · 4 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.	006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065406 application number: ANDA065406
ampicillin and sulbactam	AMPICILLIN AND SULBACTAM	Sagent Pharmaceuticals	a67ae347-487d-4751-a841-b321e81db26f	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065406 application number: ANDA065406 ndc (product): 25021-143 ndc (product): 25021-142
Ampicillin and Sulbactam	AMPICILLIN SODIUM AND SULBACTAM SODIUM	Meitheal Pharmaceuticals Inc.	e6cf14a8-3ed9-4a7a-ba69-be0b794cbdc4	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065406 application number: ANDA065406
Ampicillin and Sulbactam	AMPICILLIN AND SULBACTAM	Hikma Pharmaceuticals USA Inc.	d3026cc0-95d8-44cf-be47-b5ebb8fd4568	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065406 application number: ANDA065406 ndc (product): 0641-6117 ndc (product): 0641-6116

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0641-6116	Ampicillin and Sulbactam	Ampicillin and Sulbactam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6116	Ampicillin and Sulbactam	Ampicillin and Sulbactam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6117	Ampicillin and Sulbactam	Ampicillin and Sulbactam	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6117	Ampicillin and Sulbactam	Ampicillin and Sulbactam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6119	Ampicillin and Sulbactam	Ampicillin and Sulbactam	West-Ward Pharmaceutical Corp.	ANDA	Current
0641-6119	Ampicillin and Sulbactam	Ampicillin and Sulbactam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6120	Ampicillin and Sulbactam	Ampicillin and Sulbactam	West-Ward Pharmaceutical Corp.	ANDA	Current
0641-6120	Ampicillin and Sulbactam	Ampicillin and Sulbactam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6122	Ampicillin and Sulbactam	Ampicillin and Sulbactam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6122	Ampicillin and Sulbactam	Ampicillin and Sulbactam	West-ward Pharmaceutical Corp.	ANDA	Current
0641-6123	Ampicillin and Sulbactam	Ampicillin and Sulbactam	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6123	Ampicillin and Sulbactam	Ampicillin and Sulbactam	West-ward Pharmaceutical Corp.	ANDA	Current
25021-142	ampicillin and sulbactam	ampicillin and sulbactam	Sagent Pharmaceuticals	ANDA	Current
25021-142	ampicillin and sulbactam	ampicillin and sulbactam	Sagent Pharmaceuticals	ANDA	Current
25021-142	ampicillin and sulbactam	ampicillin and sulbactam	Sagent Pharmaceuticals	ANDA	Current
25021-142	ampicillin and sulbactam	ampicillin and sulbactam	Sagent Pharmaceuticals	ANDA	Current
25021-143	ampicillin and sulbactam	ampicillin and sulbactam	Sagent Pharmaceuticals	ANDA	Current
25021-143	ampicillin and sulbactam	ampicillin and sulbactam	Sagent Pharmaceuticals	ANDA	Current
25021-143	ampicillin and sulbactam	ampicillin and sulbactam	Sagent Pharmaceuticals	ANDA	Current
25021-143	ampicillin and sulbactam	ampicillin and sulbactam	Sagent Pharmaceuticals	ANDA	Current