Application 062251

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

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	No
002	GENTAMICIN SULFATE	GENTAMICIN SULFATE	INJECTABLE;INJECTION	EQ 10MG 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
A062251-001	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982
A062251-002	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062251-001	AP
A062251-002	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062251-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062251-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062251-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062251-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062251-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062251-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062251-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062251-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062251-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062251-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062251-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062251-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062251-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062251-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062251-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062251-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062251-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062251-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062251-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062251-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062251-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062251-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062251-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062251-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062251-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062251-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062251-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062251-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062251-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062251-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062251-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062251-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062251-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062251-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062251-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062251-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062251-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062251-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062251-001	GENTAMICIN SULFATE	EQ 40MG BASE/ML	INJECTABLE / INJECTION		Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062251-002	GENTAMICIN SULFATE	EQ 10MG BASE/ML	INJECTABLE / INJECTION		Approved before 1982	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062251-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062251-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062251-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062251-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062251-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062251-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062251-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062251-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062251-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062251-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062251-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062251-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062251-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062251-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062251-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062251-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062251-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062251-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062251-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062251-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062251-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062251-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062251-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062251-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062251-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062251-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062251-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062251-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062251-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062251-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062251-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A062251-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062251-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A062251-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062251-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062251-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062251-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062251-002	AP	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A062251-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A062251-002	AP	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gentamicin	GENTAMICIN	Hikma Pharmaceuticals USA Inc.	51fffac8-fb6e-4f7f-b2de-440252781a42	2023-09-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062251 application number: ANDA062251 ndc (product): 0143-9128 ndc (product): 0143-9129

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9128	Gentamicin	Gentamicin	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9129	Gentamicin	Gentamicin	Hikma Pharmaceuticals USA Inc.	ANDA	Current