Drug application
PREVDUO (GLYCOPYRROLATE, NEOSTIGMINE METHYLSULFATE)
Drugs@FDA NDA 216903 · AZURITY
Key facts
| Drug name | PREVDUO |
|---|---|
| Active ingredients | GLYCOPYRROLATE, NEOSTIGMINE METHYLSULFATE |
| Application type | NDA |
| Application number | 216903 |
| Company | AZURITY |
| Dosage forms | SOLUTION, INTRAVENOUS |
| Strength | 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) |
| Marketing status | Discontinued |
| Reference listed drug | Yes |
| Latest submission class | New Combination and New Formulation or New Manufacturer |
| Latest submission status date | Feb 23, 2023 |
At a glance
- 1–9 Submissions
- 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: