Application 203324

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

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