Application 064054

Type: ANDA
Sponsor: ACP NIMBLE

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
A064054-001	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT		1994-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064054-001	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	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064054-001	GENTAMICIN SULFATE	EQ 0.1% BASE	OINTMENT / TOPICAL	AT	1994-04-29	`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	A064054-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064054-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064054-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064054-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064054-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064054-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064054-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064054-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064054-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064054-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064054-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064054-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064054-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064054-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064054-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064054-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064054-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064054-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064054-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064054-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064054-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064054-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064054-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064054-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064054-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064054-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064054-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064054-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064054-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064054-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064054-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064054-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064054-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064054-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064054-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064054-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064054-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064054-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064054-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064054-001	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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gentamicin Sulfate	GENTAMICIN SULFATE	Cosette Pharmaceuticals, Inc.	16474069-510b-0754-9d78-9bc0354f6549	2023-11-23	Adverse reactions	Exact identifier application applno (ANDA): 064054 application number: ANDA064054 ndc (product): 0713-0682
Gentamicin Sulfate	GENTAMICIN SULFATE	Proficient Rx LP	cf4386ba-c62a-4ee8-ab59-1bb2e737a5da	2021-05-01	Adverse reactions	Exact identifier application applno (ANDA): 064054 application number: ANDA064054 ndc (product): 71205-560

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0682	Gentamicin Sulfate	Gentamicin Sulfate	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0682	Gentamicin Sulfate	Gentamicin Sulfate	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0682	Gentamicin Sulfate	Gentamicin Sulfate	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0682	Gentamicin Sulfate	Gentamicin Sulfate	G&W Laboratories, Inc.	ANDA	Current
71205-560	Gentamicin Sulfate	Gentamicin Sulfate	Proficient Rx LP	ANDA	Current