Application 062325

Type: ANDA
Sponsor: INTL MEDICATION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GENTAMICIN	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 40MG BASE/ML	No	No
003	GENTAMICIN	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 1MG BASE/ML	No	No
004	GENTAMICIN	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 100MG BASE/100ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	RLD / RS	Approval date
A062325-001	GENTAMICIN	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982
A062325-003	GENTAMICIN	GENTAMICIN SULFATE	EQ 1MG BASE/ML	INJECTABLE / INJECTION		1982-06-23
A062325-004	GENTAMICIN	GENTAMICIN SULFATE	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-06-23

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A062325-001	GENTAMICIN	EQ 40MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062325-003	GENTAMICIN	EQ 1MG BASE/ML	INJECTABLE / INJECTION		1982-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062325-004	GENTAMICIN	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-06-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062325-001	GENTAMICIN	EQ 40MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062325-003	GENTAMICIN	EQ 1MG BASE/ML	INJECTABLE / INJECTION		1982-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062325-004	GENTAMICIN	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062325-001	GENTAMICIN	EQ 40MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062325-003	GENTAMICIN	EQ 1MG BASE/ML	INJECTABLE / INJECTION		1982-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062325-004	GENTAMICIN	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062325-001	GENTAMICIN	EQ 40MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062325-003	GENTAMICIN	EQ 1MG BASE/ML	INJECTABLE / INJECTION		1982-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062325-004	GENTAMICIN	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062325-001	GENTAMICIN	EQ 40MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062325-003	GENTAMICIN	EQ 1MG BASE/ML	INJECTABLE / INJECTION		1982-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062325-004	GENTAMICIN	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062325-001	GENTAMICIN	EQ 40MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062325-003	GENTAMICIN	EQ 1MG BASE/ML	INJECTABLE / INJECTION		1982-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062325-004	GENTAMICIN	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062325-001	GENTAMICIN	EQ 40MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062325-003	GENTAMICIN	EQ 1MG BASE/ML	INJECTABLE / INJECTION		1982-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062325-004	GENTAMICIN	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062325-001	GENTAMICIN	EQ 40MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062325-003	GENTAMICIN	EQ 1MG BASE/ML	INJECTABLE / INJECTION		1982-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062325-004	GENTAMICIN	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062325-001	GENTAMICIN	EQ 40MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062325-003	GENTAMICIN	EQ 1MG BASE/ML	INJECTABLE / INJECTION		1982-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062325-004	GENTAMICIN	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062325-001	GENTAMICIN	EQ 40MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062325-003	GENTAMICIN	EQ 1MG BASE/ML	INJECTABLE / INJECTION		1982-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062325-004	GENTAMICIN	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062325-001	GENTAMICIN	EQ 40MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062325-003	GENTAMICIN	EQ 1MG BASE/ML	INJECTABLE / INJECTION		1982-06-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062325-004	GENTAMICIN	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062325-001	GENTAMICIN	EQ 40MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062325-003	GENTAMICIN	EQ 1MG BASE/ML	INJECTABLE / INJECTION		1982-06-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062325-004	GENTAMICIN	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062325-001	GENTAMICIN	EQ 40MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062325-003	GENTAMICIN	EQ 1MG BASE/ML	INJECTABLE / INJECTION		1982-06-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062325-004	GENTAMICIN	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062325-001	GENTAMICIN	EQ 40MG BASE/ML	INJECTABLE / INJECTION	Approved before 1982		`301d65b070ca…`

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 2 · 39 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	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Cardinal Health 107, LLC	5113bfad-42ca-4bb8-9343-0b08c6cd03f0	2026-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Preferred Pharmaceuticals Inc.	5ac8ea7a-ee89-49f5-8d30-6dbb56503d94	2026-05-05	Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin	GENTAMICIN	Eugia US LLC	60ca1487-392d-4721-aa45-3de38722896c	2026-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Gentamicin
Gentamicin	GENTAMICIN	Eugia US LLC	f8c608b3-50b8-4d5d-9e8a-e92c0d2e3cdc	2026-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Gentamicin
Gentamicin	GENTAMICIN SULFATE	Henry Schein, Inc	84f6eb1c-a287-489a-8c3e-aa5954cf1992	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Gentamicin generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Henry Schein, Inc.	913a36c3-50d6-429a-a8dd-a03126d2ca08	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Medical Purchasing Solutions, LLC	3532bb39-a1a6-9d67-e063-6294a90abc0c	2025-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Proficient Rx LP	5193ed8d-44c9-46fe-924d-93aaea922cfd	2025-05-01	Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	NuCare Pharmaceuticals,Inc.	0bef2a01-69d0-cf50-e063-6294a90a4c52	2025-02-03	Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin	GENTAMICIN	Fresenius Kabi USA, LLC	63413469-c676-48a3-a945-7d2489b535ef	2024-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Gentamicin
Gentamicin	GENTAMICIN SULFATE	Fresenius Kabi USA, LLC	84f5c763-1cd3-4d85-9afb-934db8666fbf	2024-10-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Gentamicin generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	NuCare Pharmaceuticals, Inc.	4add8f7b-48f0-6b6a-e054-00144ff88e88	2024-08-14	Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Bausch & Lomb Incorporated	41d01350-5c4b-42fc-be5f-986ceec02bd3	2024-07-22	Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	NuCare Pharmaceuticals,Inc.	82595309-304e-a221-e053-2991aa0ac0a9	2024-06-14	Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
GENTAMICIN SULFATE	GENTAMICIN SULFATE	NuCare Pharmaceuticals,Inc.	85424b40-5c2d-421d-e053-2991aa0a7771	2024-06-14	Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
GENTAMICIN	GENTAMICIN	HF Acquisition Co LLC, DBA HealthFirst	c1ff0cdc-ac5d-30ca-e053-2a95a90a5066	2024-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: GENTAMICIN
GENTAMICIN SULFATE	GENTAMICIN SULFATE	HF Acquisition Co LLC, DBA HealthFirst	e9fbe619-2afe-f1d7-e053-2a95a90aab29	2024-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Padagis Israel Pharmaceuticals Ltd	a9486ae1-350b-41c5-ae0c-a4d692bb2dfd	2024-01-15	Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
gentamicin sulfate	GENTAMICIN SULFATE	DIRECT RX	51a411a0-2671-4c1c-bf25-e29b32efed0c	2024-01-10	Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.