Orange Book product
NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT
Orange Book NDA 019797 · AZURITY PHARMACEUTICALS INC · Prescription
Key facts
| Proprietary name | NULYTELY-FLAVORED |
|---|---|
| Active ingredients | POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE |
| Strength | 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT |
| Dosage form | FOR SOLUTION |
| Route | ORAL |
| Application | NDA019797 |
| Applicant holder | AZURITY PHARMACEUTICALS INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AA |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | Yes |
| Approval date | Nov 18, 1994 |
At a glance
- 1–9 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.