Application 203595
- Type
- NDA
- Sponsor
- BRAINTREE LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SUCLEAR | MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE | SOLUTION;ORAL | 1.6GM/BOT,3.13GM/BOT,17.5GM/BOT,N/A,N/A,N/A,N/A;N/A,N/A,N/A,210GM,0.74GM,2.86GM,5.6GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |