Application 218010

Type: NDA
Sponsor: GLAUKOS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IDOSE TR	TRAVOPROST	IMPLANT;INTRACAMERAL	75MCG	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
N218010-001	IDOSE TR	TRAVOPROST	75MCG	IMPLANT / INTRACAMERAL		RLD, RS	2023-12-13

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218010-001	12201557	2030-06-18	U-4129	Drug substance, Drug product	2025-02-20
N218010-001	10206813	2030-10-17		Drug product	2023-12-22
N218010-001	11426306	2030-10-17		Drug product	2023-12-22
N218010-001	12201555	2031-02-14		Drug substance, Drug product	2025-02-20

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218010-001	NP	2026-12-13

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	N218010-001	IDOSE TR	75MCG	IMPLANT / INTRACAMERAL	RLD, RS	2023-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218010-001	IDOSE TR	75MCG	IMPLANT / INTRACAMERAL	RLD, RS	2023-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218010-001	IDOSE TR	75MCG	IMPLANT / INTRACAMERAL	RLD, RS	2023-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218010-001	IDOSE TR	75MCG	IMPLANT / INTRACAMERAL	RLD, RS	2023-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218010-001	IDOSE TR	75MCG	IMPLANT / INTRACAMERAL	RLD, RS	2023-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218010-001	IDOSE TR	75MCG	IMPLANT / INTRACAMERAL	RLD, RS	2023-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218010-001	IDOSE TR	75MCG	IMPLANT / INTRACAMERAL	RLD, RS	2023-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218010-001	IDOSE TR	75MCG	IMPLANT / INTRACAMERAL	RLD, RS	2023-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218010-001	IDOSE TR	75MCG	IMPLANT / INTRACAMERAL	RLD, RS	2023-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218010-001	IDOSE TR	75MCG	IMPLANT / INTRACAMERAL	RLD, RS	2023-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218010-001	IDOSE TR	75MCG	IMPLANT / INTRACAMERAL	RLD, RS	2023-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218010-001	IDOSE TR	75MCG	IMPLANT / INTRACAMERAL	RLD, RS	2023-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218010-001	IDOSE TR	75MCG	IMPLANT / INTRACAMERAL	RLD, RS	2023-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N218010-001	IDOSE TR	75MCG	IMPLANT / INTRACAMERAL	RLD, RS	2023-12-13	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N218010-001	IDOSE TR	75MCG	IMPLANT / INTRACAMERAL	RLD, RS	2023-12-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N218010-001	IDOSE TR	75MCG	IMPLANT / INTRACAMERAL	RLD, RS	2023-12-13	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218010-001	IDOSE TR	75MCG	IMPLANT / INTRACAMERAL	RLD, RS	2023-12-13	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 44 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	N218010-001	12201557	2030-06-18	U-4129	Drug substance, Drug product	2025-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218010-001	10206813	2030-10-17		Drug product	2023-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218010-001	11426306	2030-10-17		Drug product	2023-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218010-001	12201555	2031-02-14		Drug substance, Drug product	2025-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218010-001	12201557	2030-06-18	U-4129	Drug substance, Drug product	2025-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218010-001	10206813	2030-10-17		Drug product	2023-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218010-001	11426306	2030-10-17		Drug product	2023-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218010-001	12201555	2031-02-14		Drug substance, Drug product	2025-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218010-001	12201557	2030-06-18	U-4129	Drug substance, Drug product	2025-02-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218010-001	10206813	2030-10-17		Drug product	2023-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218010-001	11426306	2030-10-17		Drug product	2023-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218010-001	12201555	2031-02-14		Drug substance, Drug product	2025-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218010-001	12201557	2030-06-18	U-4129	Drug substance, Drug product	2025-02-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218010-001	10206813	2030-10-17		Drug product	2023-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218010-001	11426306	2030-10-17		Drug product	2023-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218010-001	12201555	2031-02-14		Drug substance, Drug product	2025-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218010-001	10206813	2030-10-17		Drug product	2023-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218010-001	11426306	2030-10-17		Drug product	2023-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218010-001	10206813	2030-10-17		Drug product	2023-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218010-001	11426306	2030-10-17		Drug product	2023-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218010-001	10206813	2030-10-17		Drug product	2023-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218010-001	11426306	2030-10-17		Drug product	2023-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218010-001	10206813	2030-10-17		Drug product	2023-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218010-001	11426306	2030-10-17		Drug product	2023-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218010-001	10206813	2030-10-17		Drug product	2023-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218010-001	11426306	2030-10-17		Drug product	2023-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218010-001	10206813	2030-10-17		Drug product	2023-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218010-001	11426306	2030-10-17		Drug product	2023-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218010-001	10206813	2030-10-17		Drug product	2023-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218010-001	11426306	2030-10-17		Drug product	2023-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218010-001	10206813	2030-10-17		Drug product	2023-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218010-001	11426306	2030-10-17		Drug product	2023-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218010-001	10206813	2030-10-17		Drug product	2023-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218010-001	11426306	2030-10-17		Drug product	2023-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N218010-001	10206813	2030-10-17		Drug product	2023-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N218010-001	11426306	2030-10-17		Drug product	2023-12-22	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N218010-001	10206813	2030-10-17		Drug product	2023-12-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N218010-001	11426306	2030-10-17		Drug product	2023-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N218010-001	10206813	2030-10-17		Drug product	2023-12-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N218010-001	11426306	2030-10-17		Drug product	2023-12-22	`1c564ffb4f44…`

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	N218010-001	NP	2026-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218010-001	NP	2026-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218010-001	NP	2026-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218010-001	NP	2026-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218010-001	NP	2026-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218010-001	NP	2026-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218010-001	NP	2026-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218010-001	NP	2026-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218010-001	NP	2026-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218010-001	NP	2026-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218010-001	NP	2026-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218010-001	NP	2026-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218010-001	NP	2026-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N218010-001	NP	2026-12-13	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N218010-001	NP	2026-12-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N218010-001	NP	2026-12-13	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218010-001	NP	2026-12-13	`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
iDose TR	TRAVOPROST INTRACAMERAL	Glaukos Corporation	92f6d3e2-8328-47df-972c-23008f4a1c1c	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 218010 application number: NDA218010

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84865	SUPPL	2026-01-28
84853	SUPPL	2026-01-28
84851	SUPPL	2026-01-28
84850	SUPPL	2026-01-28
80605	ORIG	2024-12-17
76837	ORIG	2023-12-14
76820	ORIG	2023-12-14