NDA 21551, held by Braintree. Bisacodyl; Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride.
As of Nov 14, 2026, NDA 21551 (Halflytely), held by Braintree, was first approved by FDA on May 10, 2004, with 7 approved supplements and 0 published complete response letters.
| Jul 16, 2010 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Sep 24, 2007 | Supplement 6Efficacy (new indication or use) | Approved | |
| May 10, 2004 | Original applicationNew dosage form · Standard review | Approved |
| Halflytely5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM · for solution, tablet, delayed release;oral | Bisacodyl; Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride | Discontinued |
| Halflytely5MG,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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · for solution, tablet, delayed release;oral | Bisacodyl; Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride | DiscontinuedReference drug |
| Jun 3, 2013 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jul 6, 2011 | Supplement 16REMS | Approved | |
| Jul 16, 2010 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Jan 18, 2008 | Supplement 8Manufacturing | Approved | None posted |
| Sep 24, 2007 | Supplement 6Efficacy (new indication or use) | Approved | |
| May 18, 2006 | Supplement 5Labeling · Standard review | Approved | |
| Feb 23, 2005 | Supplement 3Manufacturing · Standard review | Approved | |
| May 10, 2004 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
