Application 218158

Type: NDA
Sponsor: HARROW EYE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BYQLOVI	CLOBETASOL PROPIONATE	SUSPENSION/DROPS;OPHTHALMIC	0.05%	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
N218158-001	BYQLOVI	CLOBETASOL PROPIONATE	0.05%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	2024-03-04

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218158-001	10588913	2036-05-09		Drug product	2024-04-01
N218158-001	11376262	2036-05-09	U-19	Drug product	2024-04-01

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218158-001	NP	2027-03-04

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
2026-09-14 22:38:34	2026-08	N218158-001	BYQLOVI	0.05%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2024-03-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218158-001	BYQLOVI	0.05%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2024-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218158-001	BYQLOVI	0.05%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2024-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218158-001	BYQLOVI	0.05%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2024-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218158-001	BYQLOVI	0.05%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2024-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218158-001	CLOBETASOL PROPIONATE	0.05%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2024-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218158-001	CLOBETASOL PROPIONATE	0.05%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2024-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218158-001	CLOBETASOL PROPIONATE	0.05%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2024-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218158-001	CLOBETASOL PROPIONATE	0.05%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2024-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218158-001	CLOBETASOL PROPIONATE	0.05%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2024-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218158-001	CLOBETASOL PROPIONATE	0.05%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2024-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218158-001	CLOBETASOL PROPIONATE	0.05%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2024-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218158-001	CLOBETASOL PROPIONATE	0.05%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2024-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218158-001	CLOBETASOL PROPIONATE	0.05%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2024-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218158-001	CLOBETASOL PROPIONATE	0.05%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2024-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N218158-001	CLOBETASOL PROPIONATE	0.05%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2024-03-04	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218158-001	BYQLOVI	0.05%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2024-03-04	`a50c72e98297…`

Observed Orange Book patent history#

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	N218158-001	10588913	2036-05-09		Drug product	2024-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218158-001	11376262	2036-05-09	U-19	Drug product	2024-04-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218158-001	10588913	2036-05-09		Drug product	2024-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218158-001	11376262	2036-05-09	U-19	Drug product	2024-04-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218158-001	10588913	2036-05-09		Drug product	2024-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218158-001	11376262	2036-05-09	U-19	Drug product	2024-04-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218158-001	10588913	2036-05-09		Drug product	2024-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218158-001	11376262	2036-05-09	U-19	Drug product	2024-04-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218158-001	10588913	2036-05-09		Drug product	2024-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218158-001	11376262	2036-05-09	U-19	Drug product	2024-04-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218158-001	10588913	2036-05-09		Drug product	2024-04-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218158-001	11376262	2036-05-09	U-19	Drug product	2024-04-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218158-001	10588913	2036-05-09		Drug product	2024-04-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218158-001	11376262	2036-05-09	U-19	Drug product	2024-04-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218158-001	10588913	2036-05-09		Drug product	2024-04-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218158-001	11376262	2036-05-09	U-19	Drug product	2024-04-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218158-001	10588913	2036-05-09		Drug product	2024-04-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218158-001	11376262	2036-05-09	U-19	Drug product	2024-04-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218158-001	10588913	2036-05-09		Drug product	2024-04-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218158-001	11376262	2036-05-09	U-19	Drug product	2024-04-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218158-001	10588913	2036-05-09		Drug product	2024-04-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218158-001	11376262	2036-05-09	U-19	Drug product	2024-04-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218158-001	10588913	2036-05-09		Drug product	2024-04-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218158-001	11376262	2036-05-09	U-19	Drug product	2024-04-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218158-001	10588913	2036-05-09		Drug product	2024-04-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218158-001	11376262	2036-05-09	U-19	Drug product	2024-04-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218158-001	10588913	2036-05-09		Drug product	2024-04-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218158-001	11376262	2036-05-09	U-19	Drug product	2024-04-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218158-001	10588913	2036-05-09		Drug product	2024-04-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218158-001	11376262	2036-05-09	U-19	Drug product	2024-04-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N218158-001	10588913	2036-05-09		Drug product	2024-04-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N218158-001	11376262	2036-05-09	U-19	Drug product	2024-04-01	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218158-001	10588913	2036-05-09		Drug product	2024-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218158-001	11376262	2036-05-09	U-19	Drug product	2024-04-01	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N218158-001	NP	2027-03-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218158-001	NP	2027-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218158-001	NP	2027-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218158-001	NP	2027-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218158-001	NP	2027-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218158-001	NP	2027-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218158-001	NP	2027-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218158-001	NP	2027-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218158-001	NP	2027-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218158-001	NP	2027-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218158-001	NP	2027-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218158-001	NP	2027-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218158-001	NP	2027-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218158-001	NP	2027-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218158-001	NP	2027-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N218158-001	NP	2027-03-04	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218158-001	NP	2027-03-04	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BYQLOVI	CLOBETASOL PROPIONATE	Harrow Eye, LLC	31ca5a0f-812e-491d-aa00-d8ed424ba322	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 218158 application number: NDA218158
CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	Eyenovia, Inc.	7687c980-7006-4222-80b9-c32773772d3e	2025-04-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 218158 application number: NDA218158

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82589	ORIG	2025-06-17
81909	SUPPL	2025-04-09
81835	SUPPL	2025-04-08
77782	ORIG	2024-03-12
77728	ORIG	2024-03-06