Application 062413

Type: ANDA
Sponsor: ABBOTT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GENTAMICIN SULFATE	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 1.2MG BASE/ML	No	No
002	GENTAMICIN SULFATE	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 1.4MG BASE/ML	No	No
003	GENTAMICIN SULFATE	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 1.6MG BASE/ML	No	No
004	GENTAMICIN SULFATE	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 1.8MG BASE/ML	No	No
005	GENTAMICIN SULFATE	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	No	No
006	GENTAMICIN SULFATE	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 60MG BASE/100ML	No	No
007	GENTAMICIN SULFATE	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 70MG BASE/100ML	No	No
008	GENTAMICIN SULFATE	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 80MG BASE/100ML	No	No
009	GENTAMICIN SULFATE	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 90MG BASE/100ML	No	No
010	GENTAMICIN SULFATE	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 · 10 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A062413-001	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 1.2MG BASE/ML	INJECTABLE / INJECTION	1983-08-11
A062413-002	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 1.4MG BASE/ML	INJECTABLE / INJECTION	1983-08-11
A062413-003	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 1.6MG BASE/ML	INJECTABLE / INJECTION	1983-08-11
A062413-004	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 1.8MG BASE/ML	INJECTABLE / INJECTION	1983-08-11
A062413-005	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	1983-08-11
A062413-006	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 60MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11
A062413-007	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 70MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11
A062413-008	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 80MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11
A062413-009	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 90MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11
A062413-010	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 100MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11

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 11 · 430 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A062413-001	GENTAMICIN SULFATE	EQ 1.2MG BASE/ML	INJECTABLE / INJECTION	1983-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062413-002	GENTAMICIN SULFATE	EQ 1.4MG BASE/ML	INJECTABLE / INJECTION	1983-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062413-003	GENTAMICIN SULFATE	EQ 1.6MG BASE/ML	INJECTABLE / INJECTION	1983-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062413-004	GENTAMICIN SULFATE	EQ 1.8MG BASE/ML	INJECTABLE / INJECTION	1983-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062413-005	GENTAMICIN SULFATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	1983-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062413-006	GENTAMICIN SULFATE	EQ 60MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062413-007	GENTAMICIN SULFATE	EQ 70MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062413-008	GENTAMICIN SULFATE	EQ 80MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062413-009	GENTAMICIN SULFATE	EQ 90MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062413-010	GENTAMICIN SULFATE	EQ 100MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062413-001	GENTAMICIN SULFATE	EQ 1.2MG BASE/ML	INJECTABLE / INJECTION	1983-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062413-002	GENTAMICIN SULFATE	EQ 1.4MG BASE/ML	INJECTABLE / INJECTION	1983-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062413-003	GENTAMICIN SULFATE	EQ 1.6MG BASE/ML	INJECTABLE / INJECTION	1983-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062413-004	GENTAMICIN SULFATE	EQ 1.8MG BASE/ML	INJECTABLE / INJECTION	1983-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062413-005	GENTAMICIN SULFATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	1983-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062413-006	GENTAMICIN SULFATE	EQ 60MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062413-007	GENTAMICIN SULFATE	EQ 70MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062413-008	GENTAMICIN SULFATE	EQ 80MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062413-009	GENTAMICIN SULFATE	EQ 90MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062413-010	GENTAMICIN SULFATE	EQ 100MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062413-001	GENTAMICIN SULFATE	EQ 1.2MG BASE/ML	INJECTABLE / INJECTION	1983-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062413-002	GENTAMICIN SULFATE	EQ 1.4MG BASE/ML	INJECTABLE / INJECTION	1983-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062413-003	GENTAMICIN SULFATE	EQ 1.6MG BASE/ML	INJECTABLE / INJECTION	1983-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062413-004	GENTAMICIN SULFATE	EQ 1.8MG BASE/ML	INJECTABLE / INJECTION	1983-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062413-005	GENTAMICIN SULFATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	1983-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062413-006	GENTAMICIN SULFATE	EQ 60MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062413-007	GENTAMICIN SULFATE	EQ 70MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062413-008	GENTAMICIN SULFATE	EQ 80MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062413-009	GENTAMICIN SULFATE	EQ 90MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062413-010	GENTAMICIN SULFATE	EQ 100MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062413-001	GENTAMICIN SULFATE	EQ 1.2MG BASE/ML	INJECTABLE / INJECTION	1983-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062413-002	GENTAMICIN SULFATE	EQ 1.4MG BASE/ML	INJECTABLE / INJECTION	1983-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062413-003	GENTAMICIN SULFATE	EQ 1.6MG BASE/ML	INJECTABLE / INJECTION	1983-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062413-004	GENTAMICIN SULFATE	EQ 1.8MG BASE/ML	INJECTABLE / INJECTION	1983-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062413-005	GENTAMICIN SULFATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	1983-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062413-006	GENTAMICIN SULFATE	EQ 60MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062413-007	GENTAMICIN SULFATE	EQ 70MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062413-008	GENTAMICIN SULFATE	EQ 80MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062413-009	GENTAMICIN SULFATE	EQ 90MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062413-010	GENTAMICIN SULFATE	EQ 100MG BASE/100ML	INJECTABLE / INJECTION	1983-08-11	`31067a03dcf5…`

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 2 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gentamicin	GENTAMICIN SULFATE	Fresenius Kabi USA, LLC	0cce2238-28d3-4280-b520-ffc3067a2ffa	2023-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin	GENTAMICIN SULFATE	Fresenius Kabi USA, LLC	a73a5453-c091-43fd-aae2-d992152363b1	2023-10-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	A-S Medication Solutions	76fabcd6-4da3-49e3-85a1-ca4fac55a207	2023-05-08	Warnings, Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Medical Purchasing Solutions, LLC	a8b15217-cccb-2260-e053-2995a90a709d	2023-05-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Padagis Israel Pharmaceuticals Ltd	4cfbe37e-11d6-46fc-b287-0561387b17b7	2023-01-31	Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentamicin Sulfate in Sodium Chloride	GENTAMICIN SULFATE	Baxter Healthcare Corporation	449c9a41-d61e-49fd-b5e3-d76f74b92acf	2023-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Asclemed USA, Inc.	b59e49e0-640b-43c3-ad07-711d1bb154e9	2022-07-19	Warnings, Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Proficient Rx LP	3a6677a6-def5-443e-82bc-c185d41f03b7	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Asclemed USA, Inc.	a54e5c95-609d-4d66-9573-5d1ac78fa58f	2022-03-04	Warnings, Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Proficient Rx LP	cf4386ba-c62a-4ee8-ab59-1bb2e737a5da	2021-05-01	Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentak	GENTAMICIN SULFATE	Proficient Rx LP	aebfe247-cdf7-4acb-97b3-6d4341d7c815	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Proficient Rx LP	2098faaa-7f60-4640-8c37-19456ebba653	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE

Reported adverse events (FAERS/openFDA)#

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