Application 215092

Type: NDA
Sponsor: SANTEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMLONTI	OMIDENEPAG ISOPROPYL	SOLUTION;OPHTHALMIC	0.002%(0.02MG/ML)	No	No

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
N215092-001	OMLONTI	OMIDENEPAG ISOPROPYL	0.002%	SOLUTION / OPHTHALMIC		RLD, RS	2022-09-22

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215092-001	8648097	2029-10-13		Drug substance, Drug product	2022-10-20
N215092-001	8685986	2029-10-13		Drug product	2022-10-20
N215092-001	10179127	2035-01-08	U-3454	Drug product	2022-10-20
N215092-001	10702511	2035-01-08	U-3454	Drug product	2022-10-20
N215092-001	10765750	2035-01-08		Drug product	2022-10-20
N215092-001	11197849	2035-01-08	U-3454	Drug product	2022-10-20
N215092-001	11793798	2035-01-08	U-3454	Drug product	2023-11-09
N215092-001	12295946	2035-01-08	U-3454	Drug product	2025-07-21
N215092-001	9415038	2035-01-08	U-3454	Drug product	2022-10-20
N215092-001	RE48183	2035-01-08	U-3454	Drug product	2022-10-20
N215092-001	10774072	2035-06-10		Drug substance	2022-10-20
N215092-001	12290511	2038-12-27	U-3454		2025-07-21
N215092-001	11666563	2039-07-16	U-3454		2023-06-21

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215092-001	NCE	2027-09-22

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	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD, RS	2022-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD, RS	2022-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD, RS	2022-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD	2022-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD	2022-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD	2022-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD	2022-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD	2022-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD	2022-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD	2022-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD	2022-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD	2022-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD	2022-09-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD	2022-09-22	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD	2022-09-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD	2022-09-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD	2022-09-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD	2022-09-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD	2022-09-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD	2022-09-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD	2022-09-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD, RS	2022-09-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD, RS	2022-09-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD, RS	2022-09-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD, RS	2022-09-22	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215092-001	OMLONTI	0.002%	SOLUTION / OPHTHALMIC	RLD, RS	2022-09-22	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 272 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	N215092-001	8648097	2029-10-13		Drug substance, Drug product	2022-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215092-001	8685986	2029-10-13		Drug product	2022-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215092-001	10179127	2035-01-08	U-3454	Drug product	2022-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215092-001	10702511	2035-01-08	U-3454	Drug product	2022-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215092-001	10765750	2035-01-08		Drug product	2022-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215092-001	11197849	2035-01-08	U-3454	Drug product	2022-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215092-001	11793798	2035-01-08	U-3454	Drug product	2023-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215092-001	12295946	2035-01-08	U-3454	Drug product	2025-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215092-001	9415038	2035-01-08	U-3454	Drug product	2022-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215092-001	RE48183	2035-01-08	U-3454	Drug product	2022-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215092-001	10774072	2035-06-10		Drug substance	2022-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215092-001	12290511	2038-12-27	U-3454		2025-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215092-001	11666563	2039-07-16	U-3454		2023-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215092-001	8648097	2029-10-13		Drug substance, Drug product	2022-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215092-001	8685986	2029-10-13		Drug product	2022-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215092-001	10179127	2035-01-08	U-3454	Drug product	2022-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215092-001	10702511	2035-01-08	U-3454	Drug product	2022-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215092-001	10765750	2035-01-08		Drug product	2022-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215092-001	11197849	2035-01-08	U-3454	Drug product	2022-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215092-001	11793798	2035-01-08	U-3454	Drug product	2023-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215092-001	12295946	2035-01-08	U-3454	Drug product	2025-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215092-001	9415038	2035-01-08	U-3454	Drug product	2022-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215092-001	RE48183	2035-01-08	U-3454	Drug product	2022-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215092-001	10774072	2035-06-10		Drug substance	2022-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215092-001	12290511	2038-12-27	U-3454		2025-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215092-001	11666563	2039-07-16	U-3454		2023-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215092-001	8648097	2029-10-13		Drug substance, Drug product	2022-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215092-001	8685986	2029-10-13		Drug product	2022-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215092-001	10179127	2035-01-08	U-3454	Drug product	2022-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215092-001	10702511	2035-01-08	U-3454	Drug product	2022-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215092-001	10765750	2035-01-08		Drug product	2022-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215092-001	11197849	2035-01-08	U-3454	Drug product	2022-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215092-001	11793798	2035-01-08	U-3454	Drug product	2023-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215092-001	12295946	2035-01-08	U-3454	Drug product	2025-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215092-001	9415038	2035-01-08	U-3454	Drug product	2022-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215092-001	RE48183	2035-01-08	U-3454	Drug product	2022-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215092-001	10774072	2035-06-10		Drug substance	2022-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215092-001	12290511	2038-12-27	U-3454		2025-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215092-001	11666563	2039-07-16	U-3454		2023-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215092-001	8648097	2029-10-13		Drug substance, Drug product	2022-10-20	`fd3edfee7708…`

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	N215092-001	NCE	2027-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215092-001	NCE	2027-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215092-001	NCE	2027-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215092-001	NCE	2027-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215092-001	NCE	2027-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215092-001	NCE	2027-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215092-001	NCE	2027-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215092-001	NCE	2027-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215092-001	NCE	2027-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215092-001	NCE	2027-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215092-001	NCE	2027-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215092-001	NCE	2027-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215092-001	NCE	2027-09-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215092-001	NCE	2027-09-22	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215092-001	NCE	2027-09-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215092-001	NCE	2027-09-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215092-001	NCE	2027-09-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215092-001	NCE	2027-09-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215092-001	NCE	2027-09-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215092-001	NCE	2027-09-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215092-001	NCE	2027-09-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215092-001	NCE	2027-09-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215092-001	NCE	2027-09-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215092-001	NCE	2027-09-22	`3a93d1ddd44b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215092-001	NCE	2027-09-22	`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
Omlonti	OMIDENEPAG ISOPROPYL	Ocuvex Therapeutics, Inc.	4258e437-7e92-4b09-baf1-01cb158cfc05	2025-04-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215092 application number: NDA215092

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65086-002	Omlonti	omidenepag isopropyl	Santen Incorporated	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72425	ORIG	2022-10-20
72146	ORIG	2022-09-23
72142	ORIG	2022-09-23