Application 203324

Type: NDA
Sponsor: AVEDRO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHOTREXA	RIBOFLAVIN 5'-PHOSPHATE SODIUM	SOLUTION/DROPS;OPHTHALMIC	0.146%	Yes	Yes
002	PHOTREXA VISCOUS IN DEXTRAN 20%	RIBOFLAVIN 5'-PHOSPHATE SODIUM	SOLUTION/DROPS;OPHTHALMIC	0.146%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N203324-001	PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA	RIBOFLAVIN 5'-PHOSPHATE SODIUM	EQ 0.146% BASE/ML;EQ 0.146% BASE/ML	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2016-04-15

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.

Product history page 2 of 3 · 83 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2021-12-28 21:50 UTC	2021-12	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203324-001	PHOTREXA	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N203324-002	PHOTREXA VISCOUS IN DEXTRAN 20%	0.146%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2016-04-15	`e64feba35796…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 104 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203324-001	ODE-116	2023-04-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203324-001	ODE-121	2023-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203324-002	ODE-116	2023-04-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203324-002	ODE-121	2023-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203324-001	ODE-116	2023-04-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203324-001	ODE-121	2023-07-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203324-002	ODE-116	2023-04-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N203324-002	ODE-121	2023-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203324-001	ODE-116	2023-04-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203324-001	ODE-121	2023-07-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203324-002	ODE-116	2023-04-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N203324-002	ODE-121	2023-07-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203324-001	NP	2019-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203324-001	ODE-116	2023-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203324-001	ODE-121	2023-07-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203324-002	NP	2019-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203324-002	ODE-116	2023-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N203324-002	ODE-121	2023-07-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203324-001	ODE-116	2023-04-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203324-001	ODE-121	2023-07-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203324-002	ODE-116	2023-04-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N203324-002	ODE-121	2023-07-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203324-001	ODE-116	2023-04-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203324-001	ODE-121	2023-07-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203324-002	ODE-116	2023-04-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N203324-002	ODE-121	2023-07-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203324-001	ODE-116	2023-04-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203324-001	ODE-121	2023-07-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203324-002	ODE-116	2023-04-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203324-002	ODE-121	2023-07-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203324-001	ODE-116	2023-04-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N203324-001	ODE-121	2023-07-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N203324-002	ODE-116	2023-04-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N203324-002	ODE-121	2023-07-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203324-001	ODE-116	2023-04-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203324-001	ODE-121	2023-07-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203324-002	ODE-116	2023-04-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N203324-002	ODE-121	2023-07-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203324-001	ODE-116	2023-04-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N203324-001	ODE-121	2023-07-15	`c0c555d07b60…`

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
Photrexa Cross-linking Kit	RIBOFLAVIN 5-PHOSPHATE OPHTHALMIC	Glaukos Corporation	f82cfe92-1a24-11e3-8ffd-0800200c9a66	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203324 application number: NDA203324 ndc (product): 25357-025

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25357-022	Photrexa Viscous	riboflavin 5-phosphate in 20% dextran ophthalmic	Glaukos Corporation	NDA	Current
25357-022	Photrexa Viscous	riboflavin 5-phosphate in 20% dextran ophthalmic	Avedro, Inc.	NDA	Current
25357-022	Photrexa Viscous	riboflavin 5-phosphate in 20% dextran ophthalmic	Avedro, Inc.	NDA	Current
25357-022	Photrexa Viscous	riboflavin 5-phosphate in 20% dextran ophthalmic	Avedro, Inc.	NDA	Current
25357-023	Photrexa	riboflavin 5-phosphate ophthalmic	Glaukos Corporation	NDA	Current
25357-023	Photrexa	riboflavin 5-phosphate ophthalmic	Avedro, Inc.	NDA	Current
25357-023	Photrexa	riboflavin 5-phosphate ophthalmic	Avedro, Inc.	NDA	Current
25357-023	Photrexa	riboflavin 5-phosphate ophthalmic	Avedro, Inc.	NDA	Current
25357-025	Photrexa Cross-linking Kit	riboflavin 5-phosphate ophthalmic	Glaukos Corporation	NDA	Current
25357-025	Photrexa Cross-linking Kit	riboflavin 5-phosphate ophthalmic	Avedro, Inc.	NDA	Current
25357-025	Photrexa Cross-linking Kit	riboflavin 5-phosphate ophthalmic	Avedro, Inc.	NDA	Current
25357-025	Photrexa Cross-linking Kit	riboflavin 5-phosphate ophthalmic	Avedro, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81212	SUPPL	2025-02-11
81177	SUPPL	2025-02-10
57535	SUPPL	2019-02-13
57355	SUPPL	2019-01-28
54470	ORIG	2018-06-07
54467	ORIG	2018-06-06
45887	ORIG	2016-11-14
45886	ORIG	2016-11-14
45444	ORIG	2016-07-20
45443	ORIG	2016-07-18
19455	ORIG	2016-04-19
10196	ORIG	2016-04-19