Application 208694

Type: NDA
Sponsor: EYEVANCE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZERVIATE	CETIRIZINE HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.24% BASE	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
N208694-001	ZERVIATE	CETIRIZINE HYDROCHLORIDE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2017-05-30

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
N208694-001	8829005	2030-03-15	U-1680		2017-06-23
N208694-001	9750684	2030-03-15		Drug product	2017-09-14
N208694-001	9993471	2030-03-15	U-1680		2018-07-03
N208694-001	8829005*PED	2030-09-15		Pediatric extension
N208694-001	9254286	2032-07-09		Drug product	2017-06-23
N208694-001	9254286*PED	2033-01-09		Pediatric extension

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	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208694-001	ZERVIATE	EQ 0.24% BASE	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2017-05-30	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 246 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	N208694-001	8829005	2030-03-15	U-1680		2017-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208694-001	9750684	2030-03-15		Drug product	2017-09-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208694-001	9993471	2030-03-15	U-1680		2018-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208694-001	8829005*PED	2030-09-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208694-001	9254286	2032-07-09		Drug product	2017-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208694-001	9254286*PED	2033-01-09		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208694-001	8829005	2030-03-15	U-1680		2017-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208694-001	9750684	2030-03-15		Drug product	2017-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208694-001	9993471	2030-03-15	U-1680		2018-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208694-001	8829005*PED	2030-09-15		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208694-001	9254286	2032-07-09		Drug product	2017-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208694-001	9254286*PED	2033-01-09		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208694-001	8829005	2030-03-15	U-1680		2017-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208694-001	9750684	2030-03-15		Drug product	2017-09-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208694-001	9993471	2030-03-15	U-1680		2018-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208694-001	8829005*PED	2030-09-15		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208694-001	9254286	2032-07-09		Drug product	2017-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208694-001	9254286*PED	2033-01-09		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208694-001	8829005	2030-03-15	U-1680		2017-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208694-001	9750684	2030-03-15		Drug product	2017-09-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208694-001	9993471	2030-03-15	U-1680		2018-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208694-001	8829005*PED	2030-09-15		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208694-001	9254286	2032-07-09		Drug product	2017-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208694-001	9254286*PED	2033-01-09		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208694-001	8829005	2030-03-15	U-1680		2017-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208694-001	9750684	2030-03-15		Drug product	2017-09-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208694-001	9993471	2030-03-15	U-1680		2018-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208694-001	8829005*PED	2030-09-15		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208694-001	9254286	2032-07-09		Drug product	2017-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208694-001	9254286*PED	2033-01-09		Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208694-001	8829005	2030-03-15	U-1680		2017-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208694-001	9750684	2030-03-15		Drug product	2017-09-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208694-001	9993471	2030-03-15	U-1680		2018-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208694-001	8829005*PED	2030-09-15		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208694-001	9254286	2032-07-09		Drug product	2017-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208694-001	9254286*PED	2033-01-09		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208694-001	8829005	2030-03-15	U-1680		2017-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208694-001	9750684	2030-03-15		Drug product	2017-09-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208694-001	9993471	2030-03-15	U-1680		2018-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208694-001	8829005*PED	2030-09-15		Pediatric extension		`2680178bc6a6…`

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	N208694-001	NDF	2020-05-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208694-001	PED	2020-11-30	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N208694-001	NDF	2020-05-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208694-001	PED	2020-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208694-001	NDF	2020-05-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208694-001	PED	2020-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208694-001	NDF	2020-05-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208694-001	PED	2020-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208694-001	NDF	2020-05-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208694-001	PED	2020-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208694-001	NDF	2020-05-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208694-001	PED	2020-11-30	`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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZERVIATE	CETIRIZINE	Harrow Eye, LLC	6fc5ef4e-4aea-4c34-8d51-0c07ab9aad59	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208694 application number: NDA208694

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
71776-024	Zerviate	Cetirizine	Eyevance Pharmaceuticals	NDA	Current
71776-024	Zerviate	Cetirizine	Eyevance Pharmaceuticals	NDA	Current
71776-024	Zerviate	Cetirizine	Eyevance Pharmaceuticals	NDA	Current
71776-024	Zerviate	Cetirizine	Eyevance Pharmaceuticals	NDA	Current
71776-024	Zerviate	Cetirizine	Eyevance Pharmaceuticals	NDA	Current
71776-024	Zerviate	Cetirizine	Eyevance Pharmaceuticals	NDA	Current
71776-024	Zerviate	Cetirizine	Eyevance Pharmaceuticals	NDA	Current
71776-024	Zerviate	Cetirizine	Eyevance Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61847	SUPPL	2020-02-07
61806	SUPPL	2020-02-06
54734	ORIG	2018-07-02
54733	ORIG	2018-07-02
52420	ORIG	2018-01-01
48628	ORIG	2017-06-02
48612	ORIG	2017-06-01
51478	ORIG	2016-03-29
51477	ORIG	2015-09-15
52419	ORIG	1900-01-01
52418	ORIG	1900-01-01
52417	ORIG	1900-01-01