Application 050616

Type: NDA
Sponsor: NOVARTIS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N050616-001	TOBRADEX	DEXAMETHASONE; TOBRAMYCIN	0.1%;0.3%	OINTMENT / OPHTHALMIC		RLD, RS	1988-09-28

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050616-001	TOBRADEX	0.1%;0.3%	OINTMENT / OPHTHALMIC	RLD, RS	1988-09-28	`f41ea6bd6efb…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TobraDex	TOBRAMYCIN AND DEXAMETHASONE	Novartis Pharmaceuticals Corporation	7f310e0e-0d3b-493d-b6c4-238493a2a9b9	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050616 application number: NDA050616 ndc (product): 0078-0876

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0065-0648	TobraDex	tobramycin and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0065-0648	TobraDex	tobramycin and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0065-0648	TobraDex	tobramycin and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0065-0648	TobraDex	tobramycin and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0065-0648	TobraDex	tobramycin and dexamethasone	Alcon Laboratories, Inc.	NDA	Current
0078-0876	TobraDex	tobramycin and dexamethasone	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0876	TobraDex	tobramycin and dexamethasone	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0876	TobraDex	tobramycin and dexamethasone	Novartis Pharmaceuticals Corporation	NDA	Current
21695-628	TobraDex	tobramycin and dexamethasone	Rebel Distributors Corp	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73670	SUPPL	2023-03-03
73522	SUPPL	2023-02-16
73521	SUPPL	2023-02-16
73520	SUPPL	2023-02-16
73519	SUPPL	2023-02-16
73518	SUPPL	2023-02-16
73517	SUPPL	2023-02-16
73516	SUPPL	2023-02-16
73515	SUPPL	2023-02-16
73514	SUPPL	2023-02-16
73513	SUPPL	2023-02-16
67538	SUPPL	2021-05-18
67537	SUPPL	2021-05-18
67506	SUPPL	2021-05-17
67505	SUPPL	2021-05-17
62709	SUPPL	2020-04-28
62697	SUPPL	2020-04-28
39045	SUPPL	2004-07-21
30176	SUPPL	2004-07-21
17934	SUPPL	2004-07-21
7891	SUPPL	2004-07-21
39044	SUPPL	2004-06-28
39043	SUPPL	2004-06-28
30174	SUPPL	2004-06-28
7890	SUPPL	2004-06-28
22168	SUPPL	2003-09-11
30175	SUPPL	2003-03-26
17933	SUPPL	2003-03-26