Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204630

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PROVAYBLUE (METHYLENE BLUE)
10MG/2ML (5MG/ML)
Marketing Status: Prescription

Active Ingredient: METHYLENE BLUE
Proprietary Name: PROVAYBLUE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10MG/2ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N204630
Product Number: 002
Approval Date: Jul 18, 2019
Applicant Holder Full Name: PROVEPHARM SAS
Marketing Status:  Prescription
Patent and Exclusivity Information

PROVAYBLUE (METHYLENE BLUE)
50MG/10ML (5MG/ML)
Marketing Status: Prescription

Active Ingredient: METHYLENE BLUE
Proprietary Name: PROVAYBLUE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 50MG/10ML (5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N204630
Product Number: 001
Approval Date: Apr 8, 2016
Applicant Holder Full Name: PROVEPHARM SAS
Marketing Status:  Prescription
Patent and Exclusivity Information