Application 076491
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRILYTE | 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 |
|---|---|---|---|---|---|
| 51525-6831 | TriLyte | Polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride | Wallace Pharmaceuticals Inc. | ANDA | Current |
| 51525-6831 | TriLyte | Polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride | Wallace Pharmaceuticals Inc. | ANDA | Current |
| 51525-6831 | TriLyte | Polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride | Wallace Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31129 | ORIG | 2004-06-24 |