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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202217

PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL (BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE)
5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM
Marketing Status: Discontinued
Active Ingredient: BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Proprietary Name: PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL
Dosage Form; Route of Administration: FOR SOLUTION, TABLET, DELAYED RELEASE; ORAL
Strength: 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A202217
Product Number: 001
Approval Date: Aug 20, 2014
Applicant Holder Full Name: NOVEL LABORATORIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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