Application 064048

Type: ANDA
Sponsor: BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GENTAMICIN SULFATE	GENTAMICIN SULFATE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.3% BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A064048-001	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT		1994-05-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064048-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A064048-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064048-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064048-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064048-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064048-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064048-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064048-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064048-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064048-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064048-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064048-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064048-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064048-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064048-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064048-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064048-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064048-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064048-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064048-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064048-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064048-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064048-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064048-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064048-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064048-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064048-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064048-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064048-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064048-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064048-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064048-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064048-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064048-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064048-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064048-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064048-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064048-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064048-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064048-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064048-001	AT	1	`e64feba35796…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gentamicin Sulfate	GENTAMICIN SULFATE	Preferred Pharmaceuticals Inc.	5ac8ea7a-ee89-49f5-8d30-6dbb56503d94	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064048 application number: ANDA064048
Gentamicin Sulfate Opth Solution	GENTAMICIN SULFATE OPTH SOLUTION	Direct_Rx	e1a5bc32-f9a0-6b33-e053-2995a90ab9ac	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064048 application number: ANDA064048 ndc (product): 72189-359
Gentamicin Sulfate	GENTAMICIN SULFATE	NuCare Pharmaceuticals,Inc.	0bef2a01-69d0-cf50-e063-6294a90a4c52	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064048 application number: ANDA064048
Gentamicin Sulfate	GENTAMICIN SULFATE	Bausch & Lomb Incorporated	41d01350-5c4b-42fc-be5f-986ceec02bd3	2024-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064048 application number: ANDA064048 ndc (product): 24208-580
Gentamicin Sulfate	GENTAMICIN SULFATE	A-S Medication Solutions	76fabcd6-4da3-49e3-85a1-ca4fac55a207	2023-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064048 application number: ANDA064048 ndc (product): 50090-0569
Gentamicin Sulfate	GENTAMICIN SULFATE	Asclemed USA, Inc.	b59e49e0-640b-43c3-ad07-711d1bb154e9	2022-07-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064048 application number: ANDA064048 ndc (product): 76420-254
Gentamicin Sulfate	GENTAMICIN SULFATE	Proficient Rx LP	3a6677a6-def5-443e-82bc-c185d41f03b7	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064048 application number: ANDA064048 ndc (product): 63187-560

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24208-580	Gentamicin Sulfate	Gentamicin Sulfate	Bausch & Lomb Incorporated	ANDA	Current
24208-580	Gentamicin Sulfate	Gentamicin Sulfate	Bausch & Lomb Incorporated	ANDA	Current
24208-580	Gentamicin Sulfate	Gentamicin Sulfate	Bausch & Lomb Incorporated	ANDA	Current
24208-580	Gentamicin Sulfate	Gentamicin Sulfate	Bausch & Lomb Incorporated	ANDA	Current
45865-672	Gentamicin Sulfate	Gentamicin Sulfate	Medsource Pharmaceuticals	ANDA	Current
45865-672	Gentamicin Sulfate	Gentamicin Sulfate	Medsource Pharmaceuticals	ANDA	Current
50090-0249	Gentamicin Sulfate	Gentamicin Sulfate	A-S Medication Solutions	ANDA	Current
50090-0569	Gentamicin Sulfate	Gentamicin Sulfate	A-S Medication Solutions	ANDA	Current
50436-6752	Gentamicin Sulfate	Gentamicin Sulfate	Unit Dose Services	ANDA	Current
50436-6754	Gentamicin Sulfate	Gentamicin Sulfate	Unit Dose Services	ANDA	Current
63187-560	Gentamicin Sulfate	Gentamicin Sulfate	Proficient Rx LP	ANDA	Current
63187-560	Gentamicin Sulfate	Gentamicin Sulfate	Proficient Rx LP	ANDA	Current
63187-560	Gentamicin Sulfate	Gentamicin Sulfate	Proficient Rx LP	ANDA	Current
68788-0633	Gentamicin Sulfate	Gentamicin Sulfate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-0633	Gentamicin Sulfate	Gentamicin Sulfate	Preferred Pharmaceuticals, Inc.	ANDA	Current
72189-359	Gentamicin Sulfate Opth Solution	Gentamicin Sulfate Opth Solution	Direct_Rx	ANDA	Current
76420-254	Gentamicin Sulfate	Gentamicin Sulfate	Asclemed USA, Inc.	ANDA	Current