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GOLYTELY

NDA · New Drug Application · Sponsor: AZURITY · Approved 1984-07-13

Drug application

FDA Application #
NDA019011
Application type
New Drug Application
Brand name
GOLYTELY
Generic name
POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE
Active ingredients
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
Dosage form
FOR SOLUTION
Route
ORAL
Marketing status
Prescription
Sponsor
AZURITY
Manufacturer
Braintree Laboratories, Inc.
First approval
1984-07-13

Source

Authoritative
Drugs@FDA application overview
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