Drug application
TRILYTE (POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE and 1 more)
Drugs@FDA ANDA 076491 · AUROBINDO PHARMA USA
Key facts
| Drug name | TRILYTE |
|---|---|
| Active ingredients | POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE |
| Application type | ANDA |
| Application number | 076491 |
| Company | AUROBINDO PHARMA USA |
| Dosage forms | FOR SOLUTION, ORAL |
| Strength | 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT |
| Marketing status | Prescription |
| TE codes | AA |
| Reference listed drug | No |
| Latest submission status date | Feb 5, 2004 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- None Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
- Yes FDA letters on file
- No FDA reviews on file
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.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: