Application 208742

Type: NDA
Sponsor: OCULAR THERAPEUTIX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTENZA	DEXAMETHASONE	INSERT;OPHTHALMIC	0.4MG	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
N208742-001	DEXTENZA	DEXAMETHASONE	0.4MG	INSERT / OPHTHALMIC		RLD, RS	2018-11-30

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208742-001	8563027	2030-02-12	U-2487		2019-01-30
N208742-001	8409606	2030-05-14		Drug product	2019-01-30
N208742-001	12150896	2036-10-07	U-1680		2024-12-17
N208742-001	12150896	2036-10-07	U-3455		2024-12-17
N208742-001	11458041	2037-11-16	U-1680		2022-10-20
N208742-001	11458041	2037-11-16	U-3455		2022-10-20
N208742-001	12144889	2041-04-26	U-1680		2024-12-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208742-001	NPP	2028-04-07

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	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208742-001	DEXTENZA	0.4MG	INSERT / OPHTHALMIC	RLD, RS	2018-11-30	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 188 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	N208742-001	8563027	2030-02-12	U-2487		2019-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208742-001	8409606	2030-05-14		Drug product	2019-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208742-001	12150896	2036-10-07	U-1680		2024-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208742-001	12150896	2036-10-07	U-3455		2024-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208742-001	11458041	2037-11-16	U-1680		2022-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208742-001	11458041	2037-11-16	U-3455		2022-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208742-001	12144889	2041-04-26	U-1680		2024-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208742-001	8563027	2030-02-12	U-2487		2019-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208742-001	8409606	2030-05-14		Drug product	2019-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208742-001	12150896	2036-10-07	U-1680		2024-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208742-001	12150896	2036-10-07	U-3455		2024-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208742-001	11458041	2037-11-16	U-1680		2022-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208742-001	11458041	2037-11-16	U-3455		2022-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208742-001	12144889	2041-04-26	U-1680		2024-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208742-001	8563027	2030-02-12	U-2487		2019-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208742-001	8409606	2030-05-14		Drug product	2019-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208742-001	12150896	2036-10-07	U-1680		2024-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208742-001	12150896	2036-10-07	U-3455		2024-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208742-001	11458041	2037-11-16	U-1680		2022-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208742-001	11458041	2037-11-16	U-3455		2022-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208742-001	12144889	2041-04-26	U-1680		2024-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208742-001	8563027	2030-02-12	U-2487		2019-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208742-001	8409606	2030-05-14		Drug product	2019-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208742-001	12150896	2036-10-07	U-1680		2024-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208742-001	12150896	2036-10-07	U-3455		2024-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208742-001	11458041	2037-11-16	U-1680		2022-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208742-001	11458041	2037-11-16	U-3455		2022-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208742-001	12144889	2041-04-26	U-1680		2024-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208742-001	8563027	2030-02-12	U-2487		2019-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208742-001	8409606	2030-05-14		Drug product	2019-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208742-001	12150896	2036-10-07	U-1680		2024-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208742-001	12150896	2036-10-07	U-3455		2024-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208742-001	11458041	2037-11-16	U-1680		2022-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208742-001	11458041	2037-11-16	U-3455		2022-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208742-001	12144889	2041-04-26	U-1680		2024-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208742-001	9254267	2024-09-11		Drug product	2019-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208742-001	8563027	2030-02-12	U-2487		2019-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208742-001	8409606	2030-05-14		Drug product	2019-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208742-001	12150896	2036-10-07	U-1680		2024-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208742-001	12150896	2036-10-07	U-3455		2024-12-17	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208742-001	NPP	2028-04-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208742-001	NPP	2028-04-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208742-001	NPP	2028-04-07	`6a471c1ec25d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208742-001	I-876	2024-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208742-001	I-876	2024-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208742-001	I-876	2024-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208742-001	I-876	2024-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208742-001	I-876	2024-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208742-001	I-876	2024-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208742-001	I-876	2024-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208742-001	I-876	2024-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208742-001	I-876	2024-10-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208742-001	I-800	2022-06-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208742-001	I-876	2024-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208742-001	I-800	2022-06-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208742-001	I-876	2024-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208742-001	I-800	2022-06-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208742-001	I-876	2024-10-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208742-001	NP	2021-11-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208742-001	I-800	2022-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208742-001	I-800	2022-06-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208742-001	I-876	2024-10-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208742-001	NP	2021-11-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208742-001	I-800	2022-06-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208742-001	I-876	2024-10-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208742-001	NP	2021-11-30	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208742-001	I-800	2022-06-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208742-001	NP	2021-11-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208742-001	I-800	2022-06-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208742-001	NP	2021-11-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208742-001	I-800	2022-06-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208742-001	NP	2021-11-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208742-001	I-800	2022-06-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208742-001	NP	2021-11-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208742-001	I-800	2022-06-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208742-001	NP	2021-11-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208742-001	I-800	2022-06-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208742-001	NP	2021-11-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208742-001	I-800	2022-06-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208742-001	I-876	2024-10-07	`6a51e52b5d6a…`

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
DEXTENZA	DEXAMETHASONE	Ocular Therapeutix, Inc.	7514e6b8-c33f-4fbf-8810-ef520e1eb4bd	2025-04-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208742 application number: NDA208742 ndc (product): 70382-204

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
70382-204	DEXTENZA	dexamethasone	Ocular Therapeutix, Inc.	NDA	Current
70382-204	DEXTENZA	dexamethasone	Ocular Therapeutix, Inc.	NDA	Current
70382-204	DEXTENZA	dexamethasone	Ocular Therapeutix, Inc.	NDA	Current
70382-204	DEXTENZA	dexamethasone	Ocular Therapeutix, Inc.	NDA	Current
70382-204	DEXTENZA	dexamethasone	Ocular Therapeutix, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81908	SUPPL	2025-04-09
81834	SUPPL	2025-04-08
68963	SUPPL	2021-10-12
68961	SUPPL	2021-10-12
62023	SUPPL	2020-03-04
59840	ORIG	2019-08-26
59158	SUPPL	2019-06-21
59146	SUPPL	2019-06-21
56824	ORIG	2018-12-20