Application 217603

Type: NDA
Sponsor: TARSUS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XDEMVY	LOTILANER	SOLUTION/DROPS;OPHTHALMIC	0.25%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N217603-001	XDEMVY	LOTILANER	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2023-07-24

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217603-001	8383659	2030-01-17		Drug substance, Drug product	2023-08-23
N217603-001	10835517	2038-12-14	U-3674		2023-08-23
N217603-001	11197847	2038-12-14	U-3674		2023-08-23
N217603-001	11690826	2038-12-14	U-3674		2023-08-23
N217603-001	11690827	2038-12-14	U-3674		2023-08-23
N217603-001	11752137	2038-12-14		Drug product	2023-09-19
N217603-001	12171750	2038-12-14	U-3674		2025-01-23
N217603-001	12213964	2038-12-14		Drug product	2025-03-06
N217603-001	12364685	2038-12-14		Drug product	2025-08-07

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217603-001	NCE	2028-07-24

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
2026-08-18 06:07:40	2026-07	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N217603-001	8383659	2030-01-17		Drug substance, Drug product	2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217603-001	10835517	2038-12-14	U-3674		2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217603-001	11197847	2038-12-14	U-3674		2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217603-001	11690826	2038-12-14	U-3674		2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217603-001	11690827	2038-12-14	U-3674		2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217603-001	11752137	2038-12-14		Drug product	2023-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217603-001	12171750	2038-12-14	U-3674		2025-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217603-001	12213964	2038-12-14		Drug product	2025-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217603-001	12364685	2038-12-14		Drug product	2025-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217603-001	8383659	2030-01-17		Drug substance, Drug product	2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217603-001	10835517	2038-12-14	U-3674		2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217603-001	11197847	2038-12-14	U-3674		2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217603-001	11690826	2038-12-14	U-3674		2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217603-001	11690827	2038-12-14	U-3674		2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217603-001	11752137	2038-12-14		Drug product	2023-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217603-001	12171750	2038-12-14	U-3674		2025-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217603-001	12213964	2038-12-14		Drug product	2025-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217603-001	12364685	2038-12-14		Drug product	2025-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	8383659	2030-01-17		Drug substance, Drug product	2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	10835517	2038-12-14	U-3674		2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	11197847	2038-12-14	U-3674		2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	11690826	2038-12-14	U-3674		2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	11690827	2038-12-14	U-3674		2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	11752137	2038-12-14		Drug product	2023-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	12171750	2038-12-14	U-3674		2025-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	12213964	2038-12-14		Drug product	2025-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	12364685	2038-12-14		Drug product	2025-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217603-001	8383659	2030-01-17		Drug substance, Drug product	2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217603-001	10835517	2038-12-14	U-3674		2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217603-001	11197847	2038-12-14	U-3674		2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217603-001	11690826	2038-12-14	U-3674		2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217603-001	11690827	2038-12-14	U-3674		2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217603-001	11752137	2038-12-14		Drug product	2023-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217603-001	12171750	2038-12-14	U-3674		2025-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217603-001	12213964	2038-12-14		Drug product	2025-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217603-001	12364685	2038-12-14		Drug product	2025-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217603-001	8383659	2030-01-17		Drug substance, Drug product	2023-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217603-001	10835517	2038-12-14	U-3674		2023-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217603-001	11197847	2038-12-14	U-3674		2023-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217603-001	11690826	2038-12-14	U-3674		2023-08-23	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N217603-001	NCE	2028-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217603-001	NCE	2028-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	NCE	2028-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217603-001	NCE	2028-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217603-001	NCE	2028-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217603-001	NCE	2028-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217603-001	NCE	2028-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217603-001	NCE	2028-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217603-001	NCE	2028-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217603-001	NCE	2028-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217603-001	NCE	2028-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217603-001	NCE	2028-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217603-001	NCE	2028-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217603-001	NCE	2028-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217603-001	NCE	2028-07-24	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217603-001	NCE	2028-07-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217603-001	NCE	2028-07-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217603-001	NCE	2028-07-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217603-001	NCE	2028-07-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217603-001	NCE	2028-07-24	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217603-001	NCE	2028-07-24	`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
XDEMVY	LOTILANER OPHTHALMIC SOLUTION	Tarsus Pharmaceuticals, Inc.	ccd9e37c-654e-4e84-8c85-6523457df979	2024-08-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217603 application number: NDA217603

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75114	ORIG	2023-08-18
74897	ORIG	2023-07-26
74889	ORIG	2023-07-25