Drug application
PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID (ASCORBIC ACID, POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE and 3 more)
Drugs@FDA ANDA 090145 · NOVEL LABS INC
Key facts
| Drug name | PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID |
|---|---|
| Active ingredients | ASCORBIC ACID, POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM ASCORBATE, SODIUM CHLORIDE, SODIUM SULFATE |
| Application type | ANDA |
| Application number | 090145 |
| Company | NOVEL LABS INC |
| Dosage forms | FOR SOLUTION, ORAL |
| Strength | 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM |
| Marketing status | Prescription |
| TE codes | AA |
| Reference listed drug | No |
| Latest submission status date | Jan 25, 2012 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- 1–9 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.