Drug application
SUFLAVE (MAGNESIUM SULFATE, POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE and 2 more)
Drugs@FDA NDA 215344 · AZURITY
Key facts
| Drug name | SUFLAVE |
|---|---|
| Active ingredients | MAGNESIUM SULFATE, POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM SULFATE |
| Application type | NDA |
| Application number | 215344 |
| Company | AZURITY |
| Dosage forms | FOR SOLUTION, ORAL |
| Strength | 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT |
| Marketing status | Prescription |
| Reference listed drug | Yes |
| Latest submission class | Type 4 - New Combination |
| Latest submission status date | Jun 15, 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: