FdaApplication
ANDA 090019
Identifiers
- fda_app_no: ANDA090019
Properties
| Property | Value |
|---|---|
| applicant_name | NOVEL LABORATORIES INC |
| application_type | ANDA |
| approval_date | 2009-05-27 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE | POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT | FOR SOLUTION;ORAL |
1 product