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Generated: September 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203324

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NDA 203324 describes PHOTREXA VISCOUS IN DEXTRAN 20%, which is a drug marketed by Avedro Inc and is included in one NDA. It is available from one supplier. Additional details are available on the PHOTREXA VISCOUS IN DEXTRAN 20% profile page.

The generic ingredient in PHOTREXA VISCOUS IN DEXTRAN 20% is riboflavin 5'-phosphate sodium. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the riboflavin 5'-phosphate sodium profile page.
Summary for 203324
Tradename:PHOTREXA VISCOUS IN DEXTRAN 20%
Applicant:Avedro Inc
Ingredient:riboflavin 5'-phosphate sodium
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 203324
Suppliers and Packaging for NDA: 203324
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHOTREXA riboflavin 5'-phosphate sodium SOLUTION/DROPS;OPHTHALMIC 203324 NDA Avedro, Inc. 25357-022 25357-022-01 10 POUCH in 1 BOX (25357-022-01) > 1 POUCH in 1 POUCH > 1 SYRINGE, GLASS in 1 POUCH > 3 mL in 1 SYRINGE, GLASS
PHOTREXA VISCOUS IN DEXTRAN 20% riboflavin 5'-phosphate sodium SOLUTION/DROPS;OPHTHALMIC 203324 NDA Avedro, Inc. 25357-022 25357-022-01 10 POUCH in 1 BOX (25357-022-01) > 1 POUCH in 1 POUCH > 1 SYRINGE, GLASS in 1 POUCH > 3 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.146%
Approval Date:Apr 15, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 15, 2019
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Jul 15, 2023
Regulatory Exclusivity Use:TREATMENT OF CORNEAL ECTASIA FOLLOWING REFRACTIVE SURGERY
Regulatory Exclusivity Expiration:Apr 15, 2023
Regulatory Exclusivity Use:TREATMENT OF PROGRESSIVE KERATOCONUS

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