Application 090019
- Type
- ANDA
- Sponsor
- NOVEL LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | FOR SOLUTION;ORAL | 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 40032-050 | Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate | Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate | Novel Laboratories, Inc. | ANDA | Current |
| 43386-050 | GaviLyte - N | polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate | Lupin Pharmaceuticals,Inc. | ANDA | Current |