Application 201025

Type: ANDA
Sponsor: MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMPICILLIN SODIUM	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 250MG BASE/VIAL	No	No
002	AMPICILLIN SODIUM	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	No	No
003	AMPICILLIN SODIUM	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	No
004	AMPICILLIN SODIUM	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 2GM 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A201025-001	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09
A201025-002	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09
A201025-003	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09
A201025-004	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201025-003	AP
A201025-004	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 5 · 172 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
2026-09-14 22:38:34	2026-08	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201025-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201025-002	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2014-04-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201025-003	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201025-004	AMPICILLIN SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INJECTION	AP	2014-04-09	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A201025-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201025-002	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201025-003	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201025-004	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201025-003	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201025-004	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201025-003	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A201025-004	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201025-003	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A201025-004	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201025-003	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201025-004	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201025-003	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201025-004	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201025-003	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201025-004	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201025-003	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201025-004	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201025-003	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A201025-004	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201025-003	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A201025-004	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201025-003	AP	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201025-004	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201025-003	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A201025-004	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201025-003	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A201025-004	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201025-001	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201025-002	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201025-003	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201025-004	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201025-003	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A201025-004	AP	1	`a50c72e98297…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ampicillin	AMPICILLIN	ONESOURCE SPECIALTY PHARMA LIMITED	519f2131-79e7-569f-e063-6394a90a2f93	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201025 application number: ANDA201025
Ampicillin sodium	AMPICILLIN SODIUM	Medical Purchasing Solutions, LLC	402e7cc7-5ae8-c113-e063-6394a90aa54a	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201025 application number: ANDA201025
Ampicillin	AMPICILLIN	Armas Pharmaceuticals Inc.	34e95c91-3767-493c-8716-38e61e7c6674	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201025 application number: ANDA201025
Ampicillin sodium	AMPICILLIN	Civica, Inc.	2fd0f9fa-5b86-42f7-9a9f-767123638d39	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201025 application number: ANDA201025
Ampicillin	AMPICILLIN	Medical Purchasing Solutions, LLC	29675d9c-3248-337a-e063-6294a90a2e20	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201025 application number: ANDA201025

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9817	AMPICILLIN	AMPICILLIN	Henry Schein, Inc.	ANDA	Current
52584-350	AMPICILLIN	AMPICILLIN	General Injectables and Vaccines, Inc.	ANDA	Current
52584-350	AMPICILLIN	AMPICILLIN	General Injectables and Vaccines, Inc.	ANDA	Current
52584-350	AMPICILLIN	AMPICILLIN	General Injectables and Vaccines, Inc.	ANDA	Current
67457-350	Ampicillin	Ampicillin	Mylan Institutional LLC	ANDA	Current
67457-350	Ampicillin	Ampicillin	Mylan Institutional LLC	ANDA	Current
67457-351	Ampicillin	Ampicillin	Mylan Institutional LLC	ANDA	Current
67457-351	Ampicillin	Ampicillin	Mylan Institutional LLC	ANDA	Current
67457-351	Ampicillin	Ampicillin	Mylan Institutional LLC	ANDA	Current
67457-352	Ampicillin	Ampicillin	Mylan Institutional LLC	ANDA	Current
67457-352	Ampicillin	Ampicillin	Mylan Institutional LLC	ANDA	Current
67457-352	Ampicillin	Ampicillin	Mylan Institutional LLC	ANDA	Current
67457-353	Ampicillin	Ampicillin	Mylan Institutional LLC	ANDA	Current
67457-353	Ampicillin	Ampicillin	Mylan Institutional LLC	ANDA	Current