Application 062535

Type: ANDA
Sponsor: SANDOZ INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOBREX	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
A062535-001	TOBREX	TOBRAMYCIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT		1984-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062535-001	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	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062535-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	1984-12-13	`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	A062535-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062535-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062535-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062535-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062535-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062535-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062535-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062535-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062535-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062535-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062535-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062535-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062535-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062535-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062535-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062535-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062535-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062535-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062535-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062535-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062535-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062535-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062535-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062535-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062535-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062535-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062535-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062535-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062535-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062535-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062535-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062535-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062535-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062535-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062535-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062535-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062535-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062535-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062535-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062535-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOBRAMYCIN	TOBRAMYCIN	DirectRX	87349ae8-4709-7f5a-e053-2a91aa0ae3d1	2024-01-10	Warnings, Adverse reactions	Exact identifier ndc (product): 61919-598
Tobramycin	TOBRAMYCIN	Sandoz Inc	27e2c16e-19b0-4745-93eb-5cf99f94bb92	2021-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062535 application number: ANDA062535 ndc (product): 61314-643
Tobramycin	TOBRAMYCIN	Proficient Rx LP	4eb4dfd1-f3ae-4400-b043-910b4c77296b	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062535 application number: ANDA062535 ndc (product): 63187-973

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45865-427	Tobramycin	Tobramycin	Medsource Pharmaceuticals	ANDA	Current
49999-148	Tobramycin	tobramycin	Lake Erie Medical DBA Quaity Care Products LLC	ANDA	Current
50090-3569	Tobramycin	Tobramycin	A-S Medication Solutions	ANDA	Current
50090-3569	Tobramycin	Tobramycin	A-S Medication Solutions	ANDA	Current
50436-7392	Tobramycin	Tobramycin	Unit Dose Services	ANDA	Current
53002-9232	Tobramycin	Tobramycin	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-9232	Tobramycin	Tobramycin	RPK Pharmaceuticals, Inc.	ANDA	Current
61314-643	Tobramycin	Tobramycin	Sandoz Inc	ANDA	Current
61314-643	Tobramycin	Tobramycin	Sandoz Inc	ANDA	Current
61314-643	Tobramycin	Tobramycin	Sandoz Inc	ANDA	Current
61314-643	Tobramycin	Tobramycin	Sandoz Inc	ANDA	Current
61314-643	Tobramycin	Tobramycin	Sandoz Inc	ANDA	Current
61919-598	TOBRAMYCIN	TOBRAMYCIN	DirectRX	ANDA	Current
63187-973	Tobramycin	Tobramycin	Proficient Rx LP	ANDA	Current
63187-973	Tobramycin	Tobramycin	Proficient Rx LP	ANDA	Current
68071-4446	Tobramycin	Tobramycin	NuCare Pharmaceuticals,Inc.	ANDA	Current