Application 208912

Type: NDA
Sponsor: EYEPOINT PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXYCU KIT	DEXAMETHASONE	SUSPENSION;INTRAOCULAR	9%	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
N208912-001	DEXYCU KIT	DEXAMETHASONE	9%	SUSPENSION / INTRAOCULAR		RLD	2018-02-09

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208912-001	10799642	2032-05-11		Drug product	2021-06-11
N208912-001	10028965	2034-05-23	U-2340		2018-08-03
N208912-001	10159683	2034-05-23		Drug product	2019-01-23
N208912-001	10022502	2034-06-22	U-2340		2018-08-03
N208912-001	11097061	2039-06-23	U-3418	Drug product	2022-09-09

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	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD	2018-02-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD	2018-02-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 234 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208912-001	10799642	2032-05-11		Drug product	2021-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208912-001	10028965	2034-05-23	U-2340		2018-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208912-001	10159683	2034-05-23		Drug product	2019-01-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208912-001	10022502	2034-06-22	U-2340		2018-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208912-001	11097061	2039-06-23	U-3418	Drug product	2022-09-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208912-001	10799642	2032-05-11		Drug product	2021-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208912-001	10028965	2034-05-23	U-2340		2018-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208912-001	10159683	2034-05-23		Drug product	2019-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208912-001	10022502	2034-06-22	U-2340		2018-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208912-001	11097061	2039-06-23	U-3418	Drug product	2022-09-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208912-001	10799642	2032-05-11		Drug product	2021-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208912-001	10028965	2034-05-23	U-2340		2018-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208912-001	10159683	2034-05-23		Drug product	2019-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208912-001	10022502	2034-06-22	U-2340		2018-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208912-001	11097061	2039-06-23	U-3418	Drug product	2022-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208912-001	10799642	2032-05-11		Drug product	2021-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208912-001	10028965	2034-05-23	U-2340		2018-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208912-001	10159683	2034-05-23		Drug product	2019-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208912-001	10022502	2034-06-22	U-2340		2018-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208912-001	11097061	2039-06-23	U-3418	Drug product	2022-09-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208912-001	10799642	2032-05-11		Drug product	2021-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208912-001	10028965	2034-05-23	U-2340		2018-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208912-001	10159683	2034-05-23		Drug product	2019-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208912-001	10022502	2034-06-22	U-2340		2018-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208912-001	11097061	2039-06-23	U-3418	Drug product	2022-09-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208912-001	10799642	2032-05-11		Drug product	2021-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208912-001	10028965	2034-05-23	U-2340		2018-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208912-001	10159683	2034-05-23		Drug product	2019-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208912-001	10022502	2034-06-22	U-2340		2018-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208912-001	11097061	2039-06-23	U-3418	Drug product	2022-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208912-001	10799642	2032-05-11		Drug product	2021-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208912-001	10028965	2034-05-23	U-2340		2018-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208912-001	10159683	2034-05-23		Drug product	2019-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208912-001	10022502	2034-06-22	U-2340		2018-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208912-001	11097061	2039-06-23	U-3418	Drug product	2022-09-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208912-001	10799642	2032-05-11		Drug product	2021-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208912-001	10028965	2034-05-23	U-2340		2018-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208912-001	10159683	2034-05-23		Drug product	2019-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208912-001	10022502	2034-06-22	U-2340		2018-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208912-001	11097061	2039-06-23	U-3418	Drug product	2022-09-09	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208912-001	NP	2021-02-09	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N208912-001	NP	2021-02-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208912-001	NP	2021-02-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208912-001	NP	2021-02-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208912-001	NP	2021-02-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208912-001	NP	2021-02-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208912-001	NP	2021-02-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208912-001	NP	2021-02-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208912-001	NP	2021-02-09	`ea99ee380514…`

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 3 of 5 · 86 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	Advanced Rx of Tennessee, LLC	348f5a56-978d-4272-e063-6294a90afdb6	2025-05-07	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
MAXIDEX	DEXAMETHASONE	Harrow Eye, LLC	35e47fcd-e020-43e5-8322-41f8060d220d	2025-05-05	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	PD-Rx Pharmaceuticals, Inc.	a5609df4-4933-4f85-a7b8-bc54a70a2bac	2025-04-30	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Marlex Pharmaceuticals, Inc	7b51ffce-ec64-4b49-8870-b9666537c541	2025-04-22	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
DEXTENZA	DEXAMETHASONE	Ocular Therapeutix, Inc.	7514e6b8-c33f-4fbf-8810-ef520e1eb4bd	2025-04-18	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	3f2fe98a-ab42-4bec-bf97-c090567f9ad6	2025-04-01	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Bionpharma Inc.,	401ec088-984a-49ab-b317-747c2b9b9e22	2025-03-05	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Bionpharma Inc.,	3166db4f-66a5-496a-a194-3cc01b7347d3	2025-03-05	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals Inc.	b883860c-27ba-4bac-8ae3-4cf4d82d5071	2025-02-10	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Prasco Laboratories	bfce6b49-f7ff-4ec7-9580-b730f0a207d7	2025-02-01	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Redpharm Drug, Inc.	115e1bfb-1697-d567-e063-6394a90a78e5	2025-01-23	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Direct_Rx	e90cb7f5-5e99-fbf3-e053-2995a90a70aa	2025-01-22	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Direct_Rx	fade983c-81fb-df94-e053-6394a90a7560	2025-01-22	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Direct_Rx	044d7898-4ab6-a0b3-e063-6294a90acdba	2025-01-22	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
DEXAMETHASONE	DEXAMETHASONE	Direct Rx	cc7140de-a205-f675-e053-2995a90ac22b	2025-01-20	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals Inc.	955db121-79f4-47eb-8c10-01b2d8b411e4	2025-01-13	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Advanced Rx Pharmacy of Tennessee, LLC	fa16db27-3c8c-eb22-e053-6394a90add59	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	American Health Packaging	23deb5f1-d357-45af-9851-d1249bdfa6dd	2024-12-05	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	e652b041-2a0b-4bcd-a420-5d026302edbb	2024-09-23	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Direct_rx	214dea63-d77a-922a-e063-6294a90a967e	2024-09-04	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71879-001	Dexycu	dexamethasone	EyePoint Pharmaceuticals US, Inc	NDA	Current
71879-001	Dexycu	dexamethasone	EyePoint Pharmaceuticals US, Inc	NDA	Current
71879-001	Dexycu	dexamethasone	EyePoint Pharmaceuticals US, Inc	NDA	Current
71879-001	Dexycu	dexamethasone	EyePoint Pharmaceuticals US, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63429	SUPPL	2020-06-08
63424	SUPPL	2020-06-05
55861	ORIG	2018-10-10
52548	ORIG	2018-02-09
52529	ORIG	2018-02-09