FDA
Polyethylene Glycol 3350; Sodium Chloride; Sodium Bicarbonate; Potassium Chloride; Bisacodyl
Composition
- Active ingredients
- POLYETHYLENE GLYCOL 3350 2MG; SODIUM CHLORIDE 5MG; SODIUM BICARBONATE; POTASSIUM CHLORIDE; BISACODYL
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA090197.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Polyethylene Glycol 3350; Sodium Chloride; Sodium Bicarbonate; Potassium Chloride; Bisacodyl
- Active substance
- polyethylene glycol 3350
- Dosage form
- Solution; oral and tablet; delayed release
- Applicant
- Novel Labs Inc
- Status
- Tentative approval
- FDA approval
- 27 May 2010
- Application
- ANDA090197-001