Drug application
GOLYTELY (POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE and 2 more)
Drugs@FDA NDA 019011 · AZURITY
Key facts
| Drug name | GOLYTELY |
|---|---|
| Active ingredients | POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, SODIUM SULFATE ANHYDROUS |
| Application type | NDA |
| Application number | 019011 |
| Company | AZURITY |
| Dosage forms | FOR SOLUTION, ORAL |
| Strength | 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT |
| Marketing status | Prescription |
| TE codes | AA |
| Reference listed drug | Yes |
| Latest submission class | Type 4 - New Combination |
| Latest submission status date | Jul 13, 1984 |
At a glance
- 1–9 Submissions
- 10–99 Supplements
- 1–9 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.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: