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5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/10/2004 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21551_halflytely_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21551ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021551s000_HalfLytelyTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/03/2013 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/06/2011 SUPPL-16 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021551s016ltr.pdf
07/16/2010 SUPPL-13 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021551s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021551s013ltr.pdf
01/18/2008 SUPPL-8 Labeling-Container/Carton Labels

Label is not available on this site.

09/24/2007 SUPPL-6 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021551s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021551s006ltr.pdf
05/18/2006 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021551s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021551s005ltr.pdf
02/23/2005 SUPPL-3 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21551s003ltr.pdf
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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