Application 219910

Type: NDA
Sponsor: GLAUKOS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPIOXA HD/EPIOXA KIT	RIBOFLAVIN 5'-PHOSPHATE SODIUM	SOLUTION/DROPS;OPHTHALMIC	EQ 0.239% BASE/ML;EQ 0.177% BASE/ML	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
N219910-001	EPIOXA HD/EPIOXA KIT	RIBOFLAVIN 5'-PHOSPHATE SODIUM	EQ 0.239% BASE/ML;EQ 0.177% BASE/ML	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2025-10-17

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219910-001	NP	2028-10-17

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	N219910-001	EPIOXA HD/EPIOXA KIT	EQ 0.239% BASE/ML;EQ 0.177% BASE/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2025-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219910-001	EPIOXA HD/EPIOXA KIT	0.239%;0.177%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2025-10-17	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219910-001	EPIOXA HD/EPIOXA KIT	EQ 0.239% BASE/ML;EQ 0.177% BASE/ML	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2025-10-17	`a50c72e98297…`

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	N219910-001	NP	2028-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219910-001	NP	2028-10-17	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219910-001	NP	2028-10-17	`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
EPIOXA CROSS-LINKING	RIBOFLAVIN 5-PHOSPHATE OPHTHALMIC	Glaukos Corporation	13cefc46-337c-41a3-b113-106bfe553bbb	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219910 application number: NDA219910

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83858	ORIG	2025-10-21
83819	ORIG	2025-10-20