Application 050592

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOBRADEX	DEXAMETHASONE; TOBRAMYCIN	SUSPENSION/DROPS;OPHTHALMIC	0.1%;0.3%	Yes	Yes

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
N050592-001	TOBRADEX	DEXAMETHASONE; TOBRAMYCIN	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050592-001	AB

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050592-001	TOBRADEX	0.1%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1988-08-18	`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	N050592-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050592-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050592-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050592-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050592-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050592-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050592-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050592-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050592-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050592-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050592-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050592-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050592-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050592-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050592-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050592-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050592-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050592-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050592-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050592-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050592-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050592-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050592-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050592-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050592-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050592-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050592-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050592-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050592-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050592-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050592-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050592-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050592-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050592-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050592-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050592-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050592-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050592-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050592-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050592-001	AB	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	REMEDYREPACK INC.	c606945c-4ffc-4ee8-af04-a00de8ea9259	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050592 application number: NDA050592
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	Preferred Pharmaceuticals Inc.	8a143864-e36b-49bf-91b4-c6cc1a928031	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050592 application number: NDA050592
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	Sandoz Inc	05fd0c36-39b4-4a43-8490-eb8dfc0920ae	2025-04-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050592 application number: NDA050592 ndc (product): 61314-647
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	Advanced Rx of Tennessee, LLC	09315f0b-f15a-30d5-e063-6394a90ac8dd	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050592 application number: NDA050592
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	A-S Medication Solutions	11c2ba9a-7aa3-4f78-aa2f-2a35d2671681	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050592 application number: NDA050592
Tobramycin and Dexamethasone	TOBRAMYCIN AND DEXAMETHASONE	A-S Medication Solutions	e4ddce2f-1b91-46e1-a8f0-a38394d4e672	2023-07-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050592 application number: NDA050592 ndc (product): 50090-1135

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
0065-0647	TobraDex	tobramycin and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0065-0647	TobraDex	tobramycin and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0065-0647	TobraDex	tobramycin and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0065-0647	TobraDex	tobramycin and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0065-0647	TobraDex	tobramycin and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0065-0647	TobraDex	tobramycin and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0078-0953	TobraDex	tobramycin and dexamethasone	Novartis Pharmaceuticals Corporation	NDA	Current
21695-203	TobraDex	tobramycin and dexamethasone	Rebel Distributors Corp	NDA	Current
21695-416	Tobramycin and Dexamethasone	Tobramycin and Dexamethasone	Rebel Distributors Corp	NDA	Current
50090-1135	Tobramycin and Dexamethasone	Tobramycin and Dexamethasone	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
52959-984	Tobramycin and Dexamethasone	Tobramycin and Dexamethasone	H.J. Harkins Company, Inc.	NDA AUTHORIZED GENERIC	Current
61314-647	Tobramycin and Dexamethasone	Tobramycin and Dexamethasone	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
61314-647	Tobramycin and Dexamethasone	Tobramycin and Dexamethasone	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
61314-647	Tobramycin and Dexamethasone	Tobramycin and Dexamethasone	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
61314-647	Tobramycin and Dexamethasone	Tobramycin and Dexamethasone	Sandoz Inc.	NDA AUTHORIZED GENERIC	Current
61314-647	Tobramycin and Dexamethasone	Tobramycin and Dexamethasone	Sandoz Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85681	SUPPL	2026-04-14
85680	SUPPL	2026-04-14
67518	SUPPL	2021-05-17
67517	SUPPL	2021-05-17
67504	SUPPL	2021-05-17
67503	SUPPL	2021-05-17
62708	SUPPL	2020-04-28
62696	SUPPL	2020-04-28
17913	SUPPL	2003-07-08
7863	SUPPL	2003-07-06