Orange Book product
PEG 3350 AND ELECTROLYTES 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT
Orange Book ANDA 090186 · NOVEL LABORATORIES INC · Prescription
Key facts
| Proprietary name | PEG 3350 AND ELECTROLYTES |
|---|---|
| Active ingredients | POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, SODIUM SULFATE ANHYDROUS |
| Strength | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT |
| Dosage form | FOR SOLUTION |
| Route | ORAL |
| Application | ANDA090186 |
| Applicant holder | NOVEL LABORATORIES INC |
| Marketing status | Prescription |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | Yes |
| Approval date | Jun 1, 2009 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No 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.