Original New Drug Application Approvals by US FDA (01 - 15 May 2017)
6 days ago
New drug applications approved by US FDA as of 01 - 15 May which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
- Active Ingredient(s): polyethylene glycol (PEG) 3350; sodium ascorbate; sodium sulfate; ascorbic acid; sodium chloride; potassium chloride
- Strength: 140G; 48.11G; 9G; 7.54G; 5.2G; 2.2G
- Dosage Form: solution; oral
- Company: Salix Pharms Inc.
- Approval Date: 04 May 2018
- Submission Classification: Type 2 - New Active Ingredient
- Indication(s): Indicated for cleansing of the colon in preparation for colonoscopy in adults
- Approved Label: 04/05/2018 (PDF)