Application 062373

Type: ANDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 0.8MG BASE/ML	No	No
002	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 80MG BASE/100ML	No	No
003	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 40MG BASE/100ML	No	No
004	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 60MG BASE/100ML	No	No
005	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 100MG BASE/100ML	No	No
006	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 120MG BASE/100ML	No	Yes
007	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 1.2MG BASE/ML	No	No
008	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 1.6MG BASE/ML	No	No
009	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 2MG BASE/ML	No	Yes
010	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 2.4MG BASE/ML	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	RLD / RS	Approval date
A062373-001	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 0.8MG BASE/ML	INJECTABLE / INJECTION		1982-09-07
A062373-002	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 80MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07
A062373-003	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 40MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07
A062373-004	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 60MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07
A062373-005	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07
A062373-006	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 120MG BASE/100ML	INJECTABLE / INJECTION	RS	1982-09-07
A062373-007	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 1.2MG BASE/ML	INJECTABLE / INJECTION		1982-09-07
A062373-008	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 1.6MG BASE/ML	INJECTABLE / INJECTION		1982-09-07
A062373-009	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	RS	1982-09-07
A062373-010	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	GENTAMICIN SULFATE	EQ 2.4MG BASE/ML	INJECTABLE / INJECTION		1982-09-07

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A062373-001	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 0.8MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062373-002	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 80MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062373-003	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062373-004	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 60MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062373-005	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062373-006	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 120MG BASE/100ML	INJECTABLE / INJECTION	RS	1982-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062373-007	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.2MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062373-008	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.6MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062373-009	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2MG BASE/ML	INJECTABLE / INJECTION	RS	1982-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062373-010	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2.4MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062373-001	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 0.8MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062373-002	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 80MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062373-003	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062373-004	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 60MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062373-005	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062373-006	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 120MG BASE/100ML	INJECTABLE / INJECTION	RS	1982-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062373-007	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.2MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062373-008	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.6MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062373-009	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2MG BASE/ML	INJECTABLE / INJECTION	RS	1982-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062373-010	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2.4MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062373-001	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 0.8MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062373-002	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 80MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062373-003	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062373-004	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 60MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062373-005	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062373-006	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 120MG BASE/100ML	INJECTABLE / INJECTION	RS	1982-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062373-007	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.2MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062373-008	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.6MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062373-009	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2MG BASE/ML	INJECTABLE / INJECTION	RS	1982-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062373-010	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2.4MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062373-001	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 0.8MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062373-002	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 80MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062373-003	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 40MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062373-004	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 60MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062373-005	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 100MG BASE/100ML	INJECTABLE / INJECTION		1982-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062373-006	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 120MG BASE/100ML	INJECTABLE / INJECTION	RS	1982-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062373-007	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.2MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062373-008	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 1.6MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062373-009	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2MG BASE/ML	INJECTABLE / INJECTION	RS	1982-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062373-010	GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	EQ 2.4MG BASE/ML	INJECTABLE / INJECTION		1982-09-07	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 152 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062373-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062373-005	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062373-007	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062373-008	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062373-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062373-005	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062373-007	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062373-008	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062373-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062373-005	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062373-007	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062373-008	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062373-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062373-005	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062373-007	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062373-008	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062373-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062373-005	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062373-007	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062373-008	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062373-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062373-005	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062373-007	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062373-008	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062373-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062373-005	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062373-007	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062373-008	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062373-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062373-005	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062373-007	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062373-008	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062373-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062373-005	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062373-007	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062373-008	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062373-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A062373-005	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A062373-007	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A062373-008	AP	1	`5aa47cf7b7d7…`

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 · 31 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 SULFATE	Henry Schein, Inc	84f6eb1c-a287-489a-8c3e-aa5954cf1992	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback 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 SULFATE	Fresenius Kabi USA, LLC	84f5c763-1cd3-4d85-9afb-934db8666fbf	2024-10-11	Boxed warning, Warnings, Adverse reactions	Name fallback 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 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
Gentamicin Sulfate	GENTAMICIN SULFATE	Sandoz Inc	a213fb9c-08ea-4f30-a6c9-93c7a9ba5280	2024-01-02	Warnings, Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Cosette Pharmaceuticals, Inc.	16474069-510b-0754-9d78-9bc0354f6549	2023-11-23	Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Cosette Pharmaceuticals, Inc.	9e550dc9-509e-da05-8a97-ecbd0f5dd633	2023-11-22	Adverse reactions	Name fallback generic name: GENTAMICIN SULFATE
Gentamicin	GENTAMICIN SULFATE	Medical Purchasing Solutions, LLC	09cf88af-59da-f147-e063-6294a90aac99	2023-11-10	Boxed warning, 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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0503	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate	Baxter Healthcare Corporation	ANDA	Current
0338-0503	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate	Baxter Healthcare Corporation	ANDA	Current
0338-0503	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate	Baxter Healthcare Corporation	ANDA	Current
0338-0503	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate	Baxter Healthcare Corporation	ANDA	Current
0338-0505	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate	Baxter Healthcare Corporation	ANDA	Current
0338-0505	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate	Baxter Healthcare Corporation	ANDA	Current
0338-0505	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate	Baxter Healthcare Corporation	ANDA	Current
0338-0505	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate	Baxter Healthcare Corporation	ANDA	Current
0338-0507	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate	Baxter Healthcare Corporation	ANDA	Current
0338-0507	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate	Baxter Healthcare Corporation	ANDA	Current
0338-0507	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate	Baxter Healthcare Corporation	ANDA	Current
0338-0507	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate	Baxter Healthcare Corporation	ANDA	Current
0338-0509	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate	Baxter Healthcare Corporation	ANDA	Current
0338-0509	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate	Baxter Healthcare Corporation	ANDA	Current
0338-0509	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate	Baxter Healthcare Corporation	ANDA	Current
0338-0509	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate	Baxter Healthcare Corporation	ANDA	Current
0338-0511	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate	Baxter Healthcare Corporation	ANDA	Current
0338-0511	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate	Baxter Healthcare Corporation	ANDA	Current
0338-0511	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate	Baxter Healthcare Corporation	ANDA	Current
0338-0511	Gentamicin Sulfate in Sodium Chloride	Gentamicin Sulfate	Baxter Healthcare Corporation	ANDA	Current