Application 090186
- Type
- ANDA
- Sponsor
- NOVEL LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PEG 3350 AND ELECTROLYTES | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS | FOR SOLUTION;ORAL | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 40032-060 | Polyethylene Glycol-3350 and Electrolytes with Flavor Pack | Polyethylene Glycol-3350 and Electrolytes with Flavor Pack | Novel Laboratories, Inc. | ANDA | Current |
| 43386-060 | GaviLyte - C | polyethylene glycol-3350 and electrolytes with Flavor Pack | Lupin Pharmaceuticals,Inc. | ANDA | Current |