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PEG 3350 AND ELECTROLYTES

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVEL LABS INC · Approved 2009-06-01

Drug application

FDA Application #
ANDA090186
Application type
Abbreviated New Drug Application (Generic)
Brand name
PEG 3350 AND ELECTROLYTES
Generic name
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK
Active ingredients
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Dosage form
FOR SOLUTION
Route
ORAL
Marketing status
Prescription
Sponsor
NOVEL LABS INC
Manufacturer
Lupin Pharmaceuticals,Inc.
First approval
2009-06-01

Source

Authoritative
Drugs@FDA application overview
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