Application 062420

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GENTAMICIN SULFATE	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 10MG BASE/ML	No	No
002	GENTAMICIN SULFATE	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 40MG BASE/ML	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
A062420-001	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP		1983-08-15
A062420-002	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP		1983-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062420-001	AP
A062420-002	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	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062420-001	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062420-002	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	1983-08-15	`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	A062420-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062420-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062420-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062420-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062420-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062420-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062420-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062420-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062420-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062420-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062420-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062420-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062420-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062420-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062420-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062420-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062420-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062420-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062420-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062420-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062420-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062420-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062420-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062420-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062420-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062420-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062420-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062420-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062420-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062420-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062420-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062420-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062420-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062420-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062420-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062420-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062420-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062420-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062420-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062420-002	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gentamicin Sulfate	GENTAMICIN SULFATE	Hospira, Inc.	977180b3-a222-4282-d485-4a3217674305	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062420 application number: ANDA062420 ndc (product): 0409-1207
Gentamicin Sulfate	GENTAMICIN SULFATE	Cardinal Health 107, LLC	5113bfad-42ca-4bb8-9343-0b08c6cd03f0	2026-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062420 application number: ANDA062420 ndc (product): 55154-2392
Gentamicin Sulfate	GENTAMICIN SULFATE	Henry Schein, Inc.	913a36c3-50d6-429a-a8dd-a03126d2ca08	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062420 application number: ANDA062420 ndc (product): 0404-9865
Gentamicin Sulfate	GENTAMICIN SULFATE	Medical Purchasing Solutions, LLC	3532bb39-a1a6-9d67-e063-6294a90abc0c	2025-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062420 application number: ANDA062420
GENTAMICIN SULFATE	GENTAMICIN SULFATE	HF Acquisition Co LLC, DBA HealthFirst	e9fbe619-2afe-f1d7-e053-2a95a90aab29	2024-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062420 application number: ANDA062420 ndc (product): 51662-1597
Gentamicin Sulfate	GENTAMICIN SULFATE	Medical Purchasing Solutions, LLC	a8b15217-cccb-2260-e053-2995a90a709d	2023-05-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062420 application number: ANDA062420 ndc (product): 71872-7216

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9865	Gentamicin Sulfate	Gentamicin Sulfate	Henry Schein, Inc.	ANDA	Current
0404-9865	Gentamicin Sulfate	Gentamicin Sulfate	Henry Schein, Inc.	ANDA	Current
0409-1207	Gentamicin Sulfate	GENTAMICIN SULFATE	Hospira, Inc.	ANDA	Current
0409-1207	Gentamicin Sulfate	GENTAMICIN SULFATE	Hospira, Inc.	ANDA	Current
0409-1207	Gentamicin Sulfate	GENTAMICIN SULFATE	Hospira, Inc.	ANDA	Current
0409-1207	Gentamicin Sulfate	GENTAMICIN SULFATE	Hospira, Inc.	ANDA	Current
0409-1207	Gentamicin Sulfate	GENTAMICIN SULFATE	Hospira, Inc.	ANDA	Current
0409-1207	Gentamicin Sulfate	GENTAMICIN SULFATE	Hospira, Inc.	ANDA	Current
0409-1207	Gentamicin Sulfate	GENTAMICIN SULFATE	Hospira, Inc.	ANDA	Current
0409-1207	Gentamicin Sulfate	GENTAMICIN SULFATE	Hospira, Inc.	ANDA	Current
0409-1207	Gentamicin Sulfate	GENTAMICIN SULFATE	Hospira, Inc.	ANDA	Current
0409-1207	Gentamicin Sulfate	GENTAMICIN SULFATE	Hospira, Inc.	ANDA	Current
51662-1597	GENTAMICIN SULFATE	GENTAMICIN SULFATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-207	Gentamicin Sulfate	Gentamicin Sulfate	General Injectables & Vaccines, Inc	ANDA	Current
52584-207	Gentamicin Sulfate	Gentamicin Sulfate	General Injectables & Vaccines, Inc	ANDA	Current
52584-207	Gentamicin Sulfate	Gentamicin Sulfate	General Injectables & Vaccines, Inc	ANDA	Current
55154-2392	Gentamicin Sulfate	Gentamicin Sulfate	Cardinal Health	ANDA	Current
55154-2392	Gentamicin Sulfate	Gentamicin Sulfate	Cardinal Health 107, LLC	ANDA	Current
55154-2392	Gentamicin Sulfate	Gentamicin Sulfate	Cardinal Health	ANDA	Current
55154-2392	Gentamicin Sulfate	Gentamicin Sulfate	Cardinal Health	ANDA	Current
71872-7216	Gentamicin Sulfate	GENTAMICIN SULFATE	Medical Purchasing Solutions, LLC	ANDA	Current