Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021551

HALFLYTELY (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5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Proprietary Name: HALFLYTELY
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5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021551
Product Number: 003
Approval Date: Jul 16, 2010
Applicant Holder Full Name: BRAINTREE LABORATORIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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