Orange Book product
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT
Orange Book ANDA 204559 · STRIDES PHARMA GLOBAL PTE LTD · Prescription
Key facts
| Proprietary name | PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE |
|---|---|
| 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 | ANDA204559 |
| Applicant holder | STRIDES PHARMA GLOBAL PTE LTD |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AA |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Apr 13, 2015 |
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.