Drug application
POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE and 2 more)
Drugs@FDA ANDA 090197 · NOVEL LABS INC
Key facts
| Drug name | POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; BISACODYL |
|---|---|
| Active ingredients | POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE, BISACODYL |
| Application type | ANDA |
| Application number | 090197 |
| Company | NOVEL LABS INC |
| Dosage forms | SOLUTION, ORAL AND TABLET, DELAYED RELEASE |
| Strength | 2MG; 5MG |
| Marketing status | None (Tentative Approval) |
| Reference listed drug | No |
| Latest submission status date | May 27, 2010 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- None Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.