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POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; BISACODYL
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVEL LABS INC · Approved 2010-05-27
Drug application
- FDA Application #
ANDA090197- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; BISACODYL
- Generic name
- Polyethylene Glycol 3350
- Active ingredients
- POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE; BISACODYL
- Dosage form
- SOLUTION; ORAL AND TABLET; DELAYED RELEASE
- Route
- —
- Marketing status
- None (Tentative Approval)
- Sponsor
- NOVEL LABS INC
- First approval
- 2010-05-27
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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