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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209381

PLENVU (ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE)
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM
Marketing Status: Prescription
Active Ingredient: ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
Proprietary Name: PLENVU
Dosage Form; Route of Administration: FOR SOLUTION; ORAL
Strength: 7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209381
Product Number: 001
Approval Date: May 4, 2018
Applicant Holder Full Name: SALIX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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