← FDA DRUG APPROVALS
FDA NDA · NDA019011
GOLYTELY
polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride
Sponsor: AZURITY
APPLICATION
NDA019011
TYPE
NDA
ORIGINAL APPROVAL
1984-07-13
LATEST ACTION
2021-05-14
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription, Discontinued
Products
GOLYTELY · ReferencePrescription
POLYETHYLENE GLYCOL 3350 236GM/BOT, POTASSIUM CHLORIDE 2.97GM/BOT, SODIUM BICARBONATE 6.74GM/BOT, SODIUM CHLORIDE 5.86GM/BOT, SODIUM SULFATE ANHYDROUS 22.74GM/BOT · FOR SOLUTION · ORAL
GOLYTELY · ReferenceDiscontinued
POLYETHYLENE GLYCOL 3350 227.1GM/PACKET, POTASSIUM CHLORIDE 2.82GM/PACKET, SODIUM BICARBONATE 6.36GM/PACKET, SODIUM CHLORIDE 5.53GM/PACKET, SODIUM SULFATE ANHYDROUS 21.5GM/PACKET · FOR SOLUTION · ORAL
Approval history
2016-05-06Manufacturing (CMC) · Supplement 27 · standardAP
2015-06-05Manufacturing (CMC) · Supplement 26 · standardAP
2001-02-23Manufacturing (CMC) · Supplement 14 · standardAP
1999-10-07Manufacturing (CMC) · Supplement 13 · standardAP
1999-03-25Manufacturing (CMC) · Supplement 12 · standardAP
1997-06-03Manufacturing (CMC) · Supplement 11 · standardAP
1996-11-04Manufacturing (CMC) · Supplement 10 · standardAP
1995-10-30Manufacturing (CMC) · Supplement 9 · standardAP
1993-03-24Labeling · Supplement 8 · standardAP
1993-03-24Labeling · Supplement 7 · standardAP
1992-09-17Labeling · Supplement 6 · standardAP
1992-08-20Labeling · Supplement 5AP
1992-06-02Manufacturing (CMC) · Supplement 4 · standardAP
1986-11-05Labeling · Supplement 3AP
1985-04-19Labeling · Supplement 2AP
1985-02-22Labeling · Supplement 1AP
1984-07-13Type 4 - New Combination · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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