Application 021551
- Type
- NDA
- Sponsor
- BRAINTREE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | HALFLYTELY | BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM | No | No |
| 003 | HALFLYTELY | BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL | 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 5725 | SUPPL | 2011-07-12 |
| 43769 | ORIG | 2010-07-30 |
| 5724 | SUPPL | 2010-07-23 |
| 15773 | SUPPL | 2010-07-19 |
| 37213 | SUPPL | 2007-09-26 |
| 5723 | SUPPL | 2007-09-26 |
| 15772 | SUPPL | 2006-05-22 |
| 28104 | SUPPL | 2006-05-21 |
| 42209 | ORIG | 2005-12-01 |
| 5722 | SUPPL | 2005-03-03 |
| 15771 | ORIG | 2004-05-27 |
| 28103 | ORIG | 2004-05-26 |
| 53287 | ORIG | 1900-01-01 |
| 53286 | ORIG | 1900-01-01 |
| 53285 | ORIG | 1900-01-01 |