Drug application
PLENVU (ASCORBIC ACID, POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE and 3 more)
Drugs@FDA NDA 209381 · NORGINE
Key facts
| Drug name | PLENVU |
|---|---|
| Active ingredients | ASCORBIC ACID, POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM ASCORBATE, SODIUM CHLORIDE, SODIUM SULFATE |
| Application type | NDA |
| Application number | 209381 |
| Company | NORGINE |
| Dosage forms | FOR SOLUTION, ORAL |
| Strength | 7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM |
| Marketing status | Discontinued |
| Reference listed drug | Yes |
| Latest submission class | Type 2 - New Active Ingredient |
| Latest submission status date | May 4, 2018 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes 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: