Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021551
Company: BRAINTREE
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5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |
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 |