← FDA Drug Approvals (Drugs@FDA)
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVEL LABS INC · Approved 2009-05-27
Drug application
- FDA Application #
ANDA090019- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
- Generic name
- POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE
- Active ingredients
- POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
- Dosage form
- FOR SOLUTION
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- NOVEL LABS INC
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- First approval
- 2009-05-27
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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