Application 050541

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOBREX	TOBRAMYCIN	SOLUTION/DROPS;OPHTHALMIC	0.3%	Yes	Yes

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
N050541-001	TOBREX	TOBRAMYCIN	0.3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982

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	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050541-001	TOBREX	0.3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050541-001	TOBREX	0.3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050541-001	TOBREX	0.3% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050541-001	TOBREX	0.3%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050541-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050541-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050541-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050541-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050541-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050541-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050541-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050541-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050541-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050541-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050541-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050541-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050541-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050541-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050541-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050541-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050541-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050541-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050541-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050541-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050541-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050541-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050541-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050541-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050541-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050541-001	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 3 · 54 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOBRAMYCIN	TOBRAMYCIN	Lifestar Pharma LLC	5563e8af-c6c9-42a2-974d-7d364a47f00a	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
TOBRAMYCIN	TOBRAMYCIN	NorthStar RxLLC	7803ac83-1250-451b-8ad8-2c0a343c3031	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Preferred Pharmaceuticals Inc.	417623f1-ed48-41f5-a4b4-6f2e4a23891e	2026-07-15	Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	St. Mary's Medical Park Pharmacy	9263df93-c558-5d9f-e053-2995a90a546c	2026-06-22	Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
TOBI Podhaler	TOBRAMYCIN	Viatris Specialty LLC	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	2026-04-15	Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
TOBRAMYCIN	TOBRAMYCIN	Hospira, Inc.	c5a005b0-7b6f-4e30-df92-9a20b1ca66a1	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Sportpharm LLC	e2aa8499-2eab-4ea2-b122-6c7b1ad0c35c	2026-03-20	Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Xiromed LLC	8b50d1b5-ea8a-5844-358a-493f1965c07f	2026-02-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
tobramycin	TOBRAMYCIN	Slate Run Pharmaceuticals, LLC	ed254eec-10f4-425a-895b-66e325b7bf69	2026-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Sportpharm LLC	6ded47a3-d5c0-4616-8b7d-d6d0e6bce2a0	2026-02-05	Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	NuCare Pharmaceuticals,Inc.	b119bfa5-33b0-84eb-e053-2995a90a2cad	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	JVET PHARMACEUTICALS LLC	c6435b8f-bb6e-45e0-a52b-3087fd043b5a	2026-01-26	Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	REMEDYREPACK INC.	3596dacc-6abc-45eb-8085-fa7aaa580a1c	2026-01-21	Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	American Health Packaging	f2f8bf02-57f8-4d34-937a-32411fc6bfba	2025-12-22	Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
TOBREX	TOBRAMYCIN	Novartis Pharmaceuticals Corporation	5b66bba3-cf97-4a9c-b618-ba5f277f20f6	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: TOBREX generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Ritedose Pharmaceuticals, LLC	e8205898-0162-4e6c-bcf1-87cb074ab9ae	2025-12-10	Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
TOBI	TOBRAMYCIN	Viatris Specialty LLC	6a3c3871-1d3a-44d6-8be3-526b30123ef7	2025-11-15	Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	XGen Pharmaceuticals DJB, Inc.	a384641c-04e3-4ab5-b152-7408cd07b64d	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Preferred Pharmaceuticals Inc.	ad61ce34-8305-4fd3-bf88-a1e2438128cc	2025-09-30	Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN
Tobramycin	TOBRAMYCIN	Northstar Rx LLC	55d09ffd-4f32-8aeb-3904-8a17db635e3a	2025-09-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOBRAMYCIN

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
0065-0643	Tobrex	tobramycin	Alcon Laboratories, Inc.	NDA	Current
0065-0643	Tobrex	tobramycin	Alcon Laboratories, Inc.	NDA	Current
0065-0643	Tobrex	tobramycin	Alcon Laboratories, Inc.	NDA	Current
0065-0643	Tobrex	tobramycin	Alcon Laboratories, Inc.	NDA	Current
0065-0643	Tobrex	tobramycin	Alcon Laboratories, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67515	SUPPL	2021-05-17
67500	SUPPL	2021-05-17
62695	SUPPL	2020-04-28
62693	SUPPL	2020-04-27
17861	SUPPL	2013-01-02
30062	SUPPL	2012-12-19
38969	SUPPL	2003-07-28
7797	SUPPL	2003-07-28