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 Glaukos 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. 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 profile page.
The generic ingredient in PHOTREXA VISCOUS IN DEXTRAN 20% is riboflavin 5'-phosphate. 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 profile page.
Summary for 203324
| Tradename: | PHOTREXA VISCOUS IN DEXTRAN 20% |
| Applicant: | Glaukos |
| Ingredient: | riboflavin 5'-phosphate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203324
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PHOTREXA | riboflavin 5'-phosphate | SOLUTION/DROPS;OPHTHALMIC | 203324 | NDA | Glaukos Corporation | 25357-025 | 25357-025-03 | 2 POUCH in 1 BOX (25357-025-03) / 1 POUCH in 1 POUCH / 1 SYRINGE, GLASS in 1 POUCH / 1 KIT in 1 SYRINGE, GLASS |
| PHOTREXA VISCOUS IN DEXTRAN 20% | riboflavin 5'-phosphate | SOLUTION/DROPS;OPHTHALMIC | 203324 | NDA | Glaukos Corporation | 25357-025 | 25357-025-03 | 2 POUCH in 1 BOX (25357-025-03) / 1 POUCH in 1 POUCH / 1 SYRINGE, GLASS in 1 POUCH / 1 KIT in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.146% | ||||
| Approval Date: | Apr 15, 2016 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.146% | ||||
| Approval Date: | Apr 15, 2016 | TE: | RLD: | Yes | |||||
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