Application 050818

Type: NDA
Sponsor: EYEVANCE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOBRADEX ST	DEXAMETHASONE; TOBRAMYCIN	SUSPENSION/DROPS;OPHTHALMIC	0.05%;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
N050818-001	TOBRADEX ST	DEXAMETHASONE; TOBRAMYCIN	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	2009-02-13

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N050818-001	8101582	2027-12-19	U-1082	Drug product	2012-09-27
N050818-001	8450287	2027-12-19		Drug product	2016-02-16
N050818-001	7795316	2028-08-03	U-1082	Drug product	2010-09-30

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050818-001	TOBRADEX ST	0.05%;0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2009-02-13	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050818-001	8101582	2027-12-19	U-1082	Drug product	2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050818-001	8450287	2027-12-19		Drug product	2016-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050818-001	7795316	2028-08-03	U-1082	Drug product	2010-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050818-001	8101582	2027-12-19	U-1082	Drug product	2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050818-001	8450287	2027-12-19		Drug product	2016-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050818-001	7795316	2028-08-03	U-1082	Drug product	2010-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050818-001	8101582	2027-12-19	U-1082	Drug product	2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050818-001	8450287	2027-12-19		Drug product	2016-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050818-001	7795316	2028-08-03	U-1082	Drug product	2010-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050818-001	8101582	2027-12-19	U-1082	Drug product	2012-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050818-001	8450287	2027-12-19		Drug product	2016-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050818-001	7795316	2028-08-03	U-1082	Drug product	2010-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050818-001	8101582	2027-12-19	U-1082	Drug product	2012-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050818-001	8450287	2027-12-19		Drug product	2016-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050818-001	7795316	2028-08-03	U-1082	Drug product	2010-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050818-001	8101582	2027-12-19	U-1082	Drug product	2012-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050818-001	8450287	2027-12-19		Drug product	2016-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050818-001	7795316	2028-08-03	U-1082	Drug product	2010-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050818-001	8101582	2027-12-19	U-1082	Drug product	2012-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050818-001	8450287	2027-12-19		Drug product	2016-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050818-001	7795316	2028-08-03	U-1082	Drug product	2010-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050818-001	8101582	2027-12-19	U-1082	Drug product	2012-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050818-001	8450287	2027-12-19		Drug product	2016-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050818-001	7795316	2028-08-03	U-1082	Drug product	2010-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050818-001	8101582	2027-12-19	U-1082	Drug product	2012-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050818-001	8450287	2027-12-19		Drug product	2016-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050818-001	7795316	2028-08-03	U-1082	Drug product	2010-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050818-001	8101582	2027-12-19	U-1082	Drug product	2012-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050818-001	8450287	2027-12-19		Drug product	2016-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050818-001	7795316	2028-08-03	U-1082	Drug product	2010-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050818-001	8101582	2027-12-19	U-1082	Drug product	2012-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050818-001	8450287	2027-12-19		Drug product	2016-02-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050818-001	7795316	2028-08-03	U-1082	Drug product	2010-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050818-001	8101582	2027-12-19	U-1082	Drug product	2012-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050818-001	8450287	2027-12-19		Drug product	2016-02-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050818-001	7795316	2028-08-03	U-1082	Drug product	2010-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050818-001	8101582	2027-12-19	U-1082	Drug product	2012-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050818-001	8450287	2027-12-19		Drug product	2016-02-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050818-001	7795316	2028-08-03	U-1082	Drug product	2010-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050818-001	8101582	2027-12-19	U-1082	Drug product	2012-09-27	`8072bd15b7f6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tobradex ST	TOBRAMYCIN / DEXAMETHASONE	Harrow Eye, LLC	3b99dbb3-ac84-4d0d-b30f-a5db44fdc316	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050818 application number: NDA050818
Tobradex ST	TOBRAMYCIN / DEXAMETHASONE	Eyevance Pharmaceuticals, LLC	c2d7325e-4f58-5590-e053-2a95a90ace1b	2025-01-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050818 application number: NDA050818 ndc (product): 71776-035

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0065-0652	TOBRADEX ST	tobramycin / dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0065-0652	TOBRADEX ST	tobramycin / dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0065-0652	TOBRADEX ST	tobramycin / dexamethasone	Alcon Laboratories, Inc.	NDA	Current
71776-035	TobraDex ST	tobramycin / dexamethasone	Eyevance Pharmaceuticals LLC	NDA	Current
71776-035	TobraDex ST	tobramycin / dexamethasone	Eyevance Pharmaceuticals LLC	NDA	Current
71776-035	Tobradex ST	tobramycin / dexamethasone	Eyevance Pharmaceuticals, LLC	NDA	Current
71776-035	Tobradex ST	tobramycin / dexamethasone	Eyevance Pharmaceuticals, LLC	NDA	Current
71776-035	Tobradex ST	tobramycin / dexamethasone	Eyevance Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85536	SUPPL	2026-03-26
71838	SUPPL	2022-08-17
71837	SUPPL	2022-08-17
71836	SUPPL	2022-08-17
71823	SUPPL	2022-08-17
71822	SUPPL	2022-08-17
71821	SUPPL	2022-08-17
18297	SUPPL	2010-08-10
42753	ORIG	2010-04-21
24348	ORIG	2010-04-21
39385	ORIG	2009-03-02
30608	ORIG	2009-02-18