APPLICATION
NDA019284
TYPE
NDA
ORIGINAL APPROVAL
1986-04-30
LATEST ACTION
2007-12-07
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
OCLDiscontinued
POLYETHYLENE GLYCOL 3350 6GM/100ML, POTASSIUM CHLORIDE 75MG/100ML, SODIUM BICARBONATE 168MG/100ML, SODIUM CHLORIDE 146MG/100ML, SODIUM SULFATE 1.29GM/100ML · SOLUTION · ORAL
Approval history
2007-12-07Labeling · Supplement 13 · standardAP
2007-12-07Labeling · Supplement 11 · standardAP
2007-12-07Labeling · Supplement 9 · standardAP
2000-08-17Manufacturing (CMC) · Supplement 14 · standardAP
1999-11-04Manufacturing (CMC) · Supplement 12 · standardAP
1998-02-03Manufacturing (CMC) · Supplement 10 · standardAP
1996-07-30Manufacturing (CMC) · Supplement 8 · standardAP
1992-04-13Manufacturing (CMC) · Supplement 6 · standardAP
1988-11-22Labeling · Supplement 5AP
1988-09-30Manufacturing (CMC) · Supplement 1 · standardAP
1988-09-30Manufacturing (CMC) · Supplement 4 · standardAP
1987-11-25Labeling · Supplement 3AP
1986-04-30Type 3 - New Dosage Form · 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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