Application 062366

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GENTAMICIN SULFATE	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 40MG BASE/ML	No	Yes
002	GENTAMICIN SULFATE	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 10MG BASE/ML	No	Yes

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
A062366-001	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04
A062366-002	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062366-001	AP
A062366-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062366-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1983-08-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062366-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	RS	1986-02-06	`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	A062366-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062366-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062366-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062366-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062366-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062366-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062366-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062366-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062366-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062366-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062366-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062366-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062366-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062366-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062366-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062366-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062366-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062366-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062366-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062366-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062366-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062366-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062366-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062366-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062366-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062366-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062366-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062366-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062366-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062366-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062366-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062366-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062366-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062366-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062366-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062366-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062366-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062366-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062366-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062366-002	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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gentamicin	GENTAMICIN SULFATE	Henry Schein, Inc	84f6eb1c-a287-489a-8c3e-aa5954cf1992	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062366 application number: ANDA062366 ndc (product): 0404-9866
Gentamicin	GENTAMICIN	Fresenius Kabi USA, LLC	63413469-c676-48a3-a945-7d2489b535ef	2024-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062366 application number: ANDA062366 ndc (product): 63323-173
Gentamicin	GENTAMICIN SULFATE	Fresenius Kabi USA, LLC	84f5c763-1cd3-4d85-9afb-934db8666fbf	2024-10-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062366 application number: ANDA062366 ndc (product): 63323-010
GENTAMICIN	GENTAMICIN	HF Acquisition Co LLC, DBA HealthFirst	c1ff0cdc-ac5d-30ca-e053-2a95a90a5066	2024-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062366 application number: ANDA062366 ndc (product): 51662-1508
Gentamicin	GENTAMICIN	Fresenius Kabi USA, LLC	8bdeef7f-ad8e-46e0-a872-e945eae51d68	2023-12-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062366 application number: ANDA062366 ndc (product): 63323-173
Gentamicin	GENTAMICIN SULFATE	Medical Purchasing Solutions, LLC	09cf88af-59da-f147-e063-6294a90aac99	2023-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062366 application number: ANDA062366
Gentamicin	GENTAMICIN SULFATE	Fresenius Kabi USA, LLC	0cce2238-28d3-4280-b520-ffc3067a2ffa	2023-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062366 application number: ANDA062366 ndc (product): 63323-010
Gentamicin	GENTAMICIN	Fresenius Kabi USA, LLC	be5b414e-d598-4721-80ee-5836156ad210	2023-10-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062366 application number: ANDA062366 ndc (product): 63323-173
Gentamicin	GENTAMICIN SULFATE	Fresenius Kabi USA, LLC	a73a5453-c091-43fd-aae2-d992152363b1	2023-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062366 application number: ANDA062366 ndc (product): 63323-010

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9866	Gentamicin	Gentamicin Sulfate	Henry Schein, Inc	ANDA	Current
0404-9866	Gentamicin	Gentamicin Sulfate	Henry Schein, Inc	ANDA	Current
51662-1508	GENTAMICIN	GENTAMICIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1508	GENTAMICIN	GENTAMICIN	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
52584-010	Gentamicin	Gentamicin Sulfate	General Injectables & Vaccines, Inc	ANDA	Current
52584-010	Gentamicin	Gentamicin Sulfate	General Injectables & Vaccines, Inc	ANDA	Current
52584-010	Gentamicin	Gentamicin Sulfate	General Injectables & Vaccines, Inc	ANDA	Current
52584-010	Gentamicin	Gentamicin Sulfate	General Injectables & Vaccines, Inc	ANDA	Current
63323-010	Gentamicin	GENTAMICIN SULFATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-010	Gentamicin	GENTAMICIN SULFATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-010	Gentamicin	GENTAMICIN SULFATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-010	Gentamicin	GENTAMICIN SULFATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-010	Gentamicin	GENTAMICIN SULFATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-010	Gentamicin	GENTAMICIN SULFATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-010	Gentamicin	GENTAMICIN SULFATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-173	Gentamicin	GENTAMICIN	Fresenius Kabi USA, LLC	ANDA	Current
63323-173	Gentamicin	GENTAMICIN	Fresenius Kabi USA, LLC	ANDA	Current
63323-173	Gentamicin	GENTAMICIN	Fresenius Kabi USA, LLC	ANDA	Current
63323-173	Gentamicin	GENTAMICIN	Fresenius Kabi USA, LLC	ANDA	Current
63323-173	Gentamicin	GENTAMICIN	Fresenius Kabi USA, LLC	ANDA	Current
63323-173	Gentamicin	GENTAMICIN	Fresenius Kabi USA, LLC	ANDA	Current
63323-173	Gentamicin	GENTAMICIN	Fresenius Kabi USA, LLC	ANDA	Current
63323-173	Gentamicin	GENTAMICIN	Fresenius Kabi USA, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39398	SUPPL	2014-03-21