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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203324

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PHOTREXA (RIBOFLAVIN 5'-PHOSPHATE)
0.146%
Marketing Status: Prescription
Active Ingredient: RIBOFLAVIN 5'-PHOSPHATE
Proprietary Name: PHOTREXA
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: 0.146%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203324
Product Number: 001
Approval Date: Apr 15, 2016
Applicant Holder Full Name: GLAUKOS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
PHOTREXA VISCOUS IN DEXTRAN 20% (RIBOFLAVIN 5'-PHOSPHATE)
0.146%
Marketing Status: Prescription
Active Ingredient: RIBOFLAVIN 5'-PHOSPHATE
Proprietary Name: PHOTREXA VISCOUS IN DEXTRAN 20%
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: 0.146%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203324
Product Number: 002
Approval Date: Apr 15, 2016
Applicant Holder Full Name: GLAUKOS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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