Application 062533

Type: ANDA
Sponsor: FOUGERA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GENTAMICIN SULFATE	GENTAMICIN SULFATE	OINTMENT;TOPICAL	EQ 0.1% BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062533-001	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT		1984-10-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062533-001	AT

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062533-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1984-10-05	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062533-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062533-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062533-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062533-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062533-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062533-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062533-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062533-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062533-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062533-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062533-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062533-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062533-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062533-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062533-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062533-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062533-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062533-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062533-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062533-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062533-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062533-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062533-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062533-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062533-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062533-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062533-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062533-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062533-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062533-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062533-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062533-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062533-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062533-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062533-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062533-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062533-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062533-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062533-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062533-001	AT	1	`cb3db0bc1861…`

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 · 32 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 brand name: Gentamicin Sulfate 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 brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Preferred Pharmaceuticals Inc.	5ac8ea7a-ee89-49f5-8d30-6dbb56503d94	2026-05-05	Warnings, Adverse reactions	Name fallback brand name: Gentamicin Sulfate 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 brand name: Gentamicin Sulfate 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 brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Proficient Rx LP	5193ed8d-44c9-46fe-924d-93aaea922cfd	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	NuCare Pharmaceuticals,Inc.	0bef2a01-69d0-cf50-e063-6294a90a4c52	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: Gentamicin Sulfate 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 brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Bausch & Lomb Incorporated	41d01350-5c4b-42fc-be5f-986ceec02bd3	2024-07-22	Warnings, Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	NuCare Pharmaceuticals,Inc.	82595309-304e-a221-e053-2991aa0ac0a9	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
GENTAMICIN SULFATE	GENTAMICIN SULFATE	NuCare Pharmaceuticals,Inc.	85424b40-5c2d-421d-e053-2991aa0a7771	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: GENTAMICIN SULFATE 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 brand name: GENTAMICIN SULFATE generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Padagis Israel Pharmaceuticals Ltd	a9486ae1-350b-41c5-ae0c-a4d692bb2dfd	2024-01-15	Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
gentamicin sulfate	GENTAMICIN SULFATE	DIRECT RX	51a411a0-2671-4c1c-bf25-e29b32efed0c	2024-01-10	Warnings, Adverse reactions	Name fallback brand name: gentamicin sulfate generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Sandoz Inc	a213fb9c-08ea-4f30-a6c9-93c7a9ba5280	2024-01-02	Warnings, Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Cosette Pharmaceuticals, Inc.	16474069-510b-0754-9d78-9bc0354f6549	2023-11-23	Adverse reactions	Name fallback brand name: Gentamicin Sulfate generic name: GENTAMICIN SULFATE
Gentamicin Sulfate	GENTAMICIN SULFATE	Cosette Pharmaceuticals, Inc.	9e550dc9-509e-da05-8a97-ecbd0f5dd633	2023-11-22	Adverse reactions	Name fallback brand name: Gentamicin Sulfate 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

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0078	Gentamicin sulfate	Gentamicin Sulfate	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current