Application 062719

Type: ANDA
Sponsor: ISTITUTO BIO ITA SPA

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 1GM BASE/VIAL	No	No
003	AMPICILLIN SODIUM	AMPICILLIN SODIUM	INJECTABLE;INJECTION	EQ 500MG 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A062719-001	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12
A062719-002	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12
A062719-003	AMPICILLIN SODIUM	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A062719-001	AP
A062719-002	AP
A062719-003	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 4 · 123 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	A062719-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062719-002	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062719-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062719-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062719-002	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062719-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062719-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062719-002	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062719-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062719-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062719-002	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062719-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062719-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062719-002	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062719-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062719-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062719-002	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062719-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062719-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062719-002	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062719-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062719-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062719-002	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062719-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062719-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062719-002	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062719-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062719-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062719-002	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062719-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062719-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062719-002	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062719-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062719-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062719-002	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062719-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062719-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062719-002	AMPICILLIN SODIUM	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062719-003	AMPICILLIN SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062719-001	AMPICILLIN SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INJECTION	AP	1987-05-12	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A062719-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062719-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062719-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062719-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062719-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062719-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062719-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062719-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062719-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062719-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062719-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062719-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062719-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062719-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062719-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062719-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062719-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062719-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062719-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062719-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062719-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062719-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062719-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062719-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062719-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062719-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062719-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062719-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062719-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062719-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062719-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062719-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062719-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062719-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062719-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062719-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062719-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062719-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062719-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062719-001	AP	1	`8072bd15b7f6…`

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	AMPICILLIN	Civica, Inc.	a194f310-a669-4d8f-8c04-ee9ca01939b1	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062719 application number: ANDA062719 ndc (product): 72572-017 ndc (product): 72572-016
Ampicillin	AMPICILLIN SODIUM	NorthStar Rx, LLC	6772d650-9814-49e4-a4ec-0b1a97b837d1	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062719 application number: ANDA062719
AMPICILLIN	AMPICILLIN	HF Acquisition Co LLC, DBA HealthFirst	e47a21b1-bbdb-4321-e053-2a95a90a3b4a	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062719 application number: ANDA062719 ndc (product): 51662-1595
Ampicillin	AMPICILLIN SODIUM	Fresenius Kabi USA, LLC	8dbb4c71-8543-08f1-e053-2995a90af88d	2022-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062719 application number: ANDA062719 ndc (product): 65219-016 ndc (product): 65219-014 ndc (product): 65219-018

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51662-1595	AMPICILLIN	AMPICILLIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1595	AMPICILLIN	AMPICILLIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
63323-387	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-387	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-388	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-388	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-389	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
63323-389	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
65219-014	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
65219-014	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
65219-014	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
65219-014	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
65219-014	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
65219-016	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
65219-016	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
65219-016	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
65219-016	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
65219-016	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
65219-018	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
65219-018	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
65219-018	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
65219-018	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
65219-018	Ampicillin	ampicillin sodium	Fresenius Kabi USA, LLC	ANDA	Current
72572-016	AMPICILLIN	Ampicillin	Civica, Inc.	ANDA	Current
72572-016	AMPICILLIN	Ampicillin	Civica, Inc.	ANDA	Current
72572-016	AMPICILLIN	Ampicillin	Civica, Inc.	ANDA	Current
72572-017	AMPICILLIN	Ampicillin	Civica, Inc.	ANDA	Current