Application 201024

Type: ANDA
Sponsor: MYLAN LABS LTD

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 42.

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
A201024-001	AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP		2014-04-07
A201024-002	AMPICILLIN AND SULBACTAM	AMPICILLIN SODIUM; SULBACTAM SODIUM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP		2014-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201024-001	AP
A201024-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A201024-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201024-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201024-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201024-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201024-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201024-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201024-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201024-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201024-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201024-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201024-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201024-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201024-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201024-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201024-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201024-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201024-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201024-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201024-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201024-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201024-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201024-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201024-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201024-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201024-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201024-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201024-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201024-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201024-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201024-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201024-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201024-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201024-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201024-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201024-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201024-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201024-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201024-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201024-001	AMPICILLIN AND SULBACTAM	EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201024-002	AMPICILLIN AND SULBACTAM	EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-07	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A201024-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201024-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201024-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201024-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201024-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201024-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201024-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201024-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201024-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201024-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201024-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201024-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201024-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201024-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201024-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201024-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201024-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201024-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201024-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201024-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201024-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201024-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201024-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201024-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201024-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201024-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201024-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201024-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201024-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201024-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201024-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201024-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201024-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201024-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201024-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201024-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201024-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201024-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201024-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201024-002	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ampicillin sodium and sulbactam sodium	AMPICILLIN SODIUM AND SULBACTAM SODIUM	ONESOURCE SPECIALTY PHARMA LIMITED	44181723-ef09-301b-e063-6394a90a2cad	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201024 application number: ANDA201024
ampicillin sodium and sulbactam sodium	AMPICILLIN SODIUM AND SULBACTAM SODIUM	Civica, Inc.	e98a36a1-b75b-42b9-ad1a-05004e9587b6	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201024 application number: ANDA201024
Ampicillin Sodium and Sulbactam Sodium	AMPICILLIN SODIUM, SULBACTAM SODIUM	Armas Pharmaceuticals Inc.	ac6f8158-9d7e-4b99-af3c-0407c5287b57	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201024 application number: ANDA201024

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
67457-348	ampicillin sodium and sulbactam sodium	ampicillin sodium and sulbactam sodium	Mylan Institutional LLC	ANDA	Current
67457-348	ampicillin sodium and sulbactam sodium	ampicillin sodium and sulbactam sodium	Mylan Institutional LLC	ANDA	Current
67457-348	ampicillin sodium and sulbactam sodium	ampicillin sodium and sulbactam sodium	Mylan Institutional LLC	ANDA	Current
67457-349	ampicillin sodium and sulbactam sodium	ampicillin sodium and sulbactam sodium	Mylan Institutional LLC	ANDA	Current
67457-349	ampicillin sodium and sulbactam sodium	ampicillin sodium and sulbactam sodium	Mylan Institutional LLC	ANDA	Current
67457-349	ampicillin sodium and sulbactam sodium	ampicillin sodium and sulbactam sodium	Mylan Institutional LLC	ANDA	Current
82449-900	ampicillin sodium and sulbactam sodium	ampicillin sodium and sulbactam sodium	Steriscience Specialties Private Limited	ANDA	Current
82449-901	ampicillin sodium and sulbactam sodium	ampicillin sodium and sulbactam sodium	Steriscience Specialties Private Limited	ANDA	Current