Application 065314

Type: ANDA
Sponsor: ISTITUTO BIO ITA SPA

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 10GM BASE/VIAL;EQ 5GM 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065314-001	AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP		2006-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065314-001	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 · 41 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	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065314-001	AMPICILLIN AND SULBACTAM	EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2006-11-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A065314-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065314-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065314-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065314-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065314-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065314-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065314-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065314-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065314-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065314-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065314-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065314-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065314-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065314-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065314-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065314-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065314-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065314-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065314-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065314-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065314-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065314-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065314-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065314-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065314-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065314-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065314-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065314-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065314-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065314-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065314-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065314-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065314-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065314-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065314-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065314-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065314-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065314-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065314-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065314-001	AP	1	`cb3db0bc1861…`

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.	9f2ff165-2a21-4155-a4f0-57885a83c7dc	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065314 application number: ANDA065314
Ampicillin and Sulbactam	AMPICILLIN AND SULBACTAM	Avenacy, LLC	577dd6f0-d56a-4c82-9f72-274c3a4a0f01	2025-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065314 application number: ANDA065314
Ampicillin and Sulbactam	AMPICILLIN SODIUM AND SULBACTAM SODIUM	Meitheal Pharmaceuticals Inc.	139b4b2e-46f7-44a8-9cc1-774afa463b80	2025-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065314 application number: ANDA065314
Ampicillin and Sulbactam	AMPICILLIN SODIUM AND SULBACTAM SODIUM	NorthStar Rx, LLC	5e8d35cb-e93d-42ad-a02c-0dbf04910f61	2024-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065314 application number: ANDA065314

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63323-370	Ampicillin and Sulbactam	ampicillin sodium and sulbactam sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-370	Ampicillin and Sulbactam	ampicillin sodium and sulbactam sodium	Fresenius Kabi USA, LLC	ANDA	Current