Application 217469

Type: NDA
Sponsor: HARROW EYE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VEVYE	CYCLOSPORINE	SOLUTION;OPHTHALMIC	0.1%	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
N217469-001	VEVYE	CYCLOSPORINE	0.1%	SOLUTION / OPHTHALMIC		RLD, RS	2023-05-30

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217469-001	8614178	2030-12-13		Drug product	2023-06-22
N217469-001	12496326	2036-09-29	U-3627		2025-12-17
N217469-001	10813976	2037-09-22		Drug product	2023-06-22
N217469-001	11154513	2038-11-20	U-1900	Drug product	2023-06-22
N217469-001	11413323	2039-10-11	U-3627		2023-06-22
N217469-001	12059449	2042-04-01	U-1483	Drug product	2024-09-11

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217469-001	NP	2026-05-30

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.

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	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 96 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	N217469-001	8614178	2030-12-13		Drug product	2023-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217469-001	12496326	2036-09-29	U-3627		2025-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217469-001	10813976	2037-09-22		Drug product	2023-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217469-001	11154513	2038-11-20	U-1900	Drug product	2023-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217469-001	11413323	2039-10-11	U-3627		2023-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217469-001	12059449	2042-04-01	U-1483	Drug product	2024-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217469-001	8614178	2030-12-13		Drug product	2023-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217469-001	10813976	2037-09-22		Drug product	2023-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217469-001	11154513	2038-11-20	U-1900	Drug product	2023-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217469-001	11413323	2039-10-11	U-3627		2023-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217469-001	12059449	2042-04-01	U-1483	Drug product	2024-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217469-001	8614178	2030-12-13		Drug product	2023-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217469-001	10813976	2037-09-22		Drug product	2023-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217469-001	11154513	2038-11-20	U-1900	Drug product	2023-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217469-001	11413323	2039-10-11	U-3627		2023-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217469-001	12059449	2042-04-01	U-1483	Drug product	2024-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217469-001	8614178	2030-12-13		Drug product	2023-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217469-001	10813976	2037-09-22		Drug product	2023-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217469-001	11154513	2038-11-20	U-1900	Drug product	2023-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217469-001	11413323	2039-10-11	U-3627		2023-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217469-001	12059449	2042-04-01	U-1483	Drug product	2024-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217469-001	8614178	2030-12-13		Drug product	2023-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217469-001	10813976	2037-09-22		Drug product	2023-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217469-001	11154513	2038-11-20	U-1900	Drug product	2023-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217469-001	11413323	2039-10-11	U-3627		2023-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217469-001	12059449	2042-04-01	U-1483	Drug product	2024-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217469-001	8614178	2030-12-13		Drug product	2023-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217469-001	10813976	2037-09-22		Drug product	2023-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217469-001	11154513	2038-11-20	U-1900	Drug product	2023-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217469-001	11413323	2039-10-11	U-3627		2023-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217469-001	12059449	2042-04-01	U-1483	Drug product	2024-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217469-001	8614178	2030-12-13		Drug product	2023-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217469-001	10813976	2037-09-22		Drug product	2023-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217469-001	11154513	2038-11-20	U-1900	Drug product	2023-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217469-001	11413323	2039-10-11	U-3627		2023-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217469-001	12059449	2042-04-01	U-1483	Drug product	2024-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217469-001	8614178	2030-12-13		Drug product	2023-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217469-001	10813976	2037-09-22		Drug product	2023-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217469-001	11154513	2038-11-20	U-1900	Drug product	2023-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217469-001	11413323	2039-10-11	U-3627		2023-06-22	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217469-001	NP	2026-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217469-001	NP	2026-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217469-001	NP	2026-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217469-001	NP	2026-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217469-001	NP	2026-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217469-001	NP	2026-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217469-001	NP	2026-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217469-001	NP	2026-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217469-001	NP	2026-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217469-001	NP	2026-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217469-001	NP	2026-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217469-001	NP	2026-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217469-001	NP	2026-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217469-001	NP	2026-05-30	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217469-001	NP	2026-05-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217469-001	NP	2026-05-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217469-001	NP	2026-05-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217469-001	NP	2026-05-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217469-001	NP	2026-05-30	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217469-001	NP	2026-05-30	`a50c72e98297…`

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
VEVYE	CYCLOSPORINE OPHTHALMIC SOLUTION	Harrow Eye, LLC	0a60fccf-7e1b-44fe-e063-6394a90aadd5	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217469 application number: NDA217469

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83403	SUPPL	2025-09-19
83396	SUPPL	2025-09-19
78577	SUPPL	2024-05-29
78570	SUPPL	2024-05-29
77507	ORIG	2024-02-15
74413	ORIG	2023-05-31
74409	ORIG	2023-05-31