← FDA Drug Approvals (Drugs@FDA)
PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVEL LABS INC · Approved 2012-01-25
Drug application
- FDA Application #
ANDA090145- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
- Generic name
- PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
- Active ingredients
- ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
- Dosage form
- FOR SOLUTION
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- NOVEL LABS INC
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- First approval
- 2012-01-25
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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