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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021551
Company: BRAINTREE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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 FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL Discontinued None No No
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5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/16/2010 SUPPL-13 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021551s013lbl.pdf
09/24/2007 SUPPL-6 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021551s006lbl.pdf
05/18/2006 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021551s005lbl.pdf
05/10/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21551_halflytely_lbl.pdf
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