Application 064052

Type: ANDA
Sponsor: BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOBRAMYCIN	TOBRAMYCIN	SOLUTION/DROPS;OPHTHALMIC	0.3%	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
A064052-001	TOBRAMYCIN	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		1993-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064052-001	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	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064052-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1993-11-29	`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	A064052-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064052-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064052-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064052-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064052-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064052-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064052-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064052-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064052-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064052-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064052-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064052-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064052-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064052-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064052-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064052-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064052-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064052-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064052-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064052-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064052-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064052-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064052-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064052-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064052-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064052-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064052-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064052-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064052-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064052-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064052-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064052-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064052-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064052-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064052-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064052-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064052-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064052-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064052-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064052-001	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tobramycin	TOBRAMYCIN	Preferred Pharmaceuticals Inc.	417623f1-ed48-41f5-a4b4-6f2e4a23891e	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064052 application number: ANDA064052
Tobramycin	TOBRAMYCIN	Sportpharm LLC	6ded47a3-d5c0-4616-8b7d-d6d0e6bce2a0	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064052 application number: ANDA064052
Tobramycin	TOBRAMYCIN	Advanced Rx Pharmacy of Tennessee, LLC	fc734c2d-0d45-195c-e053-6394a90a2a92	2024-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064052 application number: ANDA064052
Tobramycin	TOBRAMYCIN	NuCare Pharmaceuticals,Inc.	58b1fa9d-a302-6dc6-e053-2991aa0a3741	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064052 application number: ANDA064052 ndc (product): 66267-936
Tobramycin	TOBRAMYCIN	Asclemed USA, Inc.	c6f9c6b1-2c45-4f6b-a1fb-e55d74fc04c3	2024-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064052 application number: ANDA064052
Tobramycin	TOBRAMYCIN	Bausch & Lomb Incorporated	a5693ec9-d2f7-4d45-90b0-a113c54840d7	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064052 application number: ANDA064052 ndc (product): 24208-290
Tobramycin	TOBRAMYCIN	A-S Medication Solutions	774b608b-d6d9-4349-8772-11c69897be42	2023-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064052 application number: ANDA064052 ndc (product): 50090-2127
Tobramycin	TOBRAMYCIN	Proficient Rx LP	d8235017-cb52-44d4-a6e6-6ee3f00c47d2	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064052 application number: ANDA064052 ndc (product): 63187-024

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13985-743	Tobramycin	Tobramycin	MWI	ANDA	Current
24208-290	Tobramycin	Tobramycin	Bausch & Lomb Incorporated	ANDA	Current
24208-290	Tobramycin	Tobramycin	Bausch & Lomb Incorporated	ANDA	Current
24208-290	Tobramycin	Tobramycin	Bausch & Lomb Incorporated	ANDA	Current
24208-290	Tobramycin	Tobramycin	Bausch & Lomb Incorporated	ANDA	Current
24208-290	Tobramycin	Tobramycin	Bausch & Lomb Incorporated	ANDA	Current
24208-290	Tobramycin	Tobramycin	Bausch & Lomb Incorporated	ANDA	Current
24208-290	Tobramycin	Tobramycin	Bausch & Lomb Incorporated	ANDA	Current
24208-290	Tobramycin	Tobramycin	Bausch & Lomb Incorporated	ANDA	Current
42254-187	Tobramycin	Tobramycin	Rebel Distributors Corp	ANDA	Current
50090-2127	Tobramycin	Tobramycin	A-S Medication Solutions	ANDA	Current
50090-2127	Tobramycin	Tobramycin	A-S Medication Solutions	ANDA	Current
52959-108	Tobramycin	Tobramycin	H.J. Harkins Company, Inc.	ANDA	Current
53002-9230	Tobramycin	Tobramycin	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-9230	Tobramycin	Tobramycin	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-380	Tobramycin	Tobramycin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-224	TOBRAMYCIN	TOBRAMYCIN	Direct Rx	ANDA	Current
63187-024	Tobramycin	Tobramycin	Proficient Rx LP	ANDA	Current
63187-024	Tobramycin	Tobramycin	Proficient Rx LP	ANDA	Current
63187-024	Tobramycin	Tobramycin	Proficient Rx LP	ANDA	Current
66267-936	Tobramycin	Tobramycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-936	Tobramycin	Tobramycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-936	Tobramycin	Tobramycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-936	Tobramycin	Tobramycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8248	Tobramycin	Tobramycin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9870	Tobramycin	Tobramycin	Preferred Pharmaceuticals	ANDA	Current
70518-0319	Tobramycin	Tobramycin	REMEDYREPACK INC.	ANDA	Current
70518-0319	Tobramycin	Tobramycin	REMEDYREPACK INC.	ANDA	Current