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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021881

MOVIPREP (ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE)
4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM
Marketing Status: Prescription
Active Ingredient: ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
Proprietary Name: MOVIPREP
Dosage Form; Route of Administration: FOR SOLUTION; ORAL
Strength: 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AA
Application Number: N021881
Product Number: 001
Approval Date: Aug 2, 2006
Applicant Holder Full Name: SALIX PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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