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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216264

BLUDIGO (INDIGOTINDISULFONATE SODIUM)
40MG/5ML (8MG/ML)
Marketing Status: Prescription
Active Ingredient: INDIGOTINDISULFONATE SODIUM
Proprietary Name: BLUDIGO
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 40MG/5ML (8MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216264
Product Number: 001
Approval Date: Jul 8, 2022
Applicant Holder Full Name: PROVEPHARM SAS
Marketing Status:  Prescription
Patent and Exclusivity Information
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