Product Details for: Luxturna Product Label Grayed out Product Label links indicate that there is no product label available for the product.
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Product Number | Dosage Form | Route of Administration | Strength | Product Presentation | License Type | Proprietary Name | Marketing Status |
---|---|---|---|---|---|---|---|
001 | Injection | Intraocular | 1.5X10 TO 11 ML | Single-Dose Vial | 351(a) | Luxturna | Rx |
Proper Name
Voretigene Neparvovec
BLA Number
125610
Applicant
Spark Therapeutics, Inc.
Original Approval Date
December 19, 2017
Date of First Licensure