Application 207444

Type: ANDA
Sponsor: SOMERSET THERAPS LLC

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
A207444-001	TOBRAMYCIN	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207444-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	2017-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207444-001	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		2017-06-28	`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	A207444-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207444-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207444-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207444-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207444-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207444-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207444-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207444-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207444-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207444-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207444-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207444-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207444-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207444-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207444-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207444-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207444-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207444-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207444-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207444-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207444-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207444-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207444-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207444-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207444-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207444-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207444-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207444-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207444-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207444-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207444-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207444-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207444-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207444-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207444-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207444-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207444-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207444-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207444-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207444-001	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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tobramycin	TOBRAMYCIN	St. Mary's Medical Park Pharmacy	9263df93-c558-5d9f-e053-2995a90a546c	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207444 application number: ANDA207444 ndc (product): 60760-583
Tobramycin	TOBRAMYCIN	Sportpharm LLC	e2aa8499-2eab-4ea2-b122-6c7b1ad0c35c	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207444 application number: ANDA207444
Tobramycin	TOBRAMYCIN	NuCare Pharmaceuticals,Inc.	b119bfa5-33b0-84eb-e053-2995a90a2cad	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207444 application number: ANDA207444 ndc (product): 68071-2272
Tobramycin	TOBRAMYCIN	REMEDYREPACK INC.	3596dacc-6abc-45eb-8085-fa7aaa580a1c	2026-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207444 application number: ANDA207444 ndc (product): 70518-1370
Tobramycin	TOBRAMYCIN	Preferred Pharmaceuticals Inc.	ad61ce34-8305-4fd3-bf88-a1e2438128cc	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207444 application number: ANDA207444 ndc (product): 68788-7252
Tobramycin	TOBRAMYCIN	Somerset Therapeutics, LLC	7333280d-5d2a-4609-ab93-3ab7031b65db	2025-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207444 application number: ANDA207444 ndc (product): 70069-131
TOBRAMYCIN	TOBRAMYCIN	DirectRX	87349ae8-4709-7f5a-e053-2a91aa0ae3d1	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207444 application number: ANDA207444 ndc (product): 61919-642
Tobramycin	TOBRAMYCIN	A-S Medication Solutions	94ef5b16-4882-4994-a905-1ee617516186	2024-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207444 application number: ANDA207444 ndc (product): 50090-4190
Tobramycin	TOBRAMYCIN	Proficient Rx LP	2f95ece0-62f7-47f4-b7ab-90f95fa3dc27	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207444 application number: ANDA207444 ndc (product): 71205-101
Tobramycin	TOBRAMYCIN	Asclemed USA, Inc.	5564e780-2320-4ce7-b211-806ca99110c3	2020-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207444 application number: ANDA207444 ndc (product): 76420-092

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45865-119	Tobramycin	Tobramycin	Medsource Pharmaceuticals	ANDA	Current
50090-4190	Tobramycin	Tobramycin	A-S Medication Solutions	ANDA	Current
50090-4190	Tobramycin	Tobramycin	A-S Medication Solutions	ANDA	Current
53002-9233	Tobramycin	Tobramycin	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-747	Tobramycin	Tobramycin	Quality Care Products, LLC	ANDA	Current
55700-747	Tobramycin	Tobramycin	Quality Care Products, LLC	ANDA	Current
55700-747	Tobramycin	Tobramycin	Quality Care Products, LLC	ANDA	Current
60760-583	Tobramycin	Tobramycin	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-642	TOBRAMYCIN	TOBRAMYCIN	DirectRX	ANDA	Current
68071-2272	Tobramycin	Tobramycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2272	Tobramycin	Tobramycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4537	Tobramycin	Tobramycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4537	Tobramycin	Tobramycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7252	Tobramycin	Tobramycin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7252	Tobramycin	Tobramycin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7252	Tobramycin	Tobramycin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7252	Tobramycin	Tobramycin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7252	Tobramycin	Tobramycin	Preferred Pharmaceuticals	ANDA	Current
70069-131	Tobramycin	Tobramycin	Somerset Therapeutics, LLC	ANDA	Current
70069-131	Tobramycin	Tobramycin	Somerset Therapeutics, LLC	ANDA	Current
70069-131	Tobramycin	Tobramycin	Somerset Therapeutics, LLC	ANDA	Current
70069-131	Tobramycin	Tobramycin	Somerset Therapeutics, LLC	ANDA	Current
70518-1370	Tobramycin	Tobramycin	REMEDYREPACK INC.	ANDA	Current
70518-1370	Tobramycin	Tobramycin	REMEDYREPACK INC.	ANDA	Current
70518-1370	Tobramycin	Tobramycin	REMEDYREPACK INC.	ANDA	Current
70518-1370	Tobramycin	Tobramycin	REMEDYREPACK INC.	ANDA	Current
70518-1370	Tobramycin	Tobramycin	REMEDYREPACK INC.	ANDA	Current
70518-1370	Tobramycin	Tobramycin	REMEDYREPACK INC.	ANDA	Current
71205-101	Tobramycin	Tobramycin	Proficient Rx LP	ANDA	Current
71205-101	Tobramycin	Tobramycin	Proficient Rx LP	ANDA	Current
71205-101	Tobramycin	Tobramycin	Proficient Rx LP	ANDA	Current
71205-101	Tobramycin	Tobramycin	Proficient Rx LP	ANDA	Current
71205-101	Tobramycin	Tobramycin	Proficient Rx LP	ANDA	Current
76420-092	Tobramycin	Tobramycin	Asclemed USA, Inc.	ANDA	Current