Orange Book product
GOLYTELY 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21…
Orange Book NDA 019011 · AZURITY PHARMACEUTICALS INC · Discontinued
Key facts
| Proprietary name | GOLYTELY |
|---|---|
| Active ingredients | POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, SODIUM SULFATE ANHYDROUS |
| Strength | 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET |
| Dosage form | FOR SOLUTION |
| Route | ORAL |
| Application | NDA019011 |
| Applicant holder | AZURITY PHARMACEUTICALS INC |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | No |
| Approval date | Jun 2, 1992 |
At a glance
- None Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.