FdaApplication
NDA 021551
Identifiers
- fda_app_no: NDA021551
Properties
| Property | Value |
|---|---|
| applicant_name | BRAINTREE LABORATORIES INC |
| application_type | NDA |
| approval_date | 2010-07-16 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| 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 |
| 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5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL |
2 products