APPLICATION
NDA018983
TYPE
NDA
ORIGINAL APPROVAL
1984-10-26
LATEST ACTION
2021-05-14
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued
Products
COLYTE-FLAVORED · ReferenceDiscontinued
POLYETHYLENE GLYCOL 3350 240GM/BOT, POTASSIUM CHLORIDE 2.98GM/BOT, SODIUM BICARBONATE 6.72GM/BOT, SODIUM CHLORIDE 5.84GM/BOT, SODIUM SULFATE ANHYDROUS 22.72GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SOLUTION · ORAL
COLYTE · ReferenceDiscontinued
POLYETHYLENE GLYCOL 3350 240GM/BOT, POTASSIUM CHLORIDE 2.98GM/BOT, SODIUM BICARBONATE 6.72GM/BOT, SODIUM CHLORIDE 5.84GM/BOT, SODIUM SULFATE ANHYDROUS 22.72GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SOLUTION · ORAL
COLYTE · ReferenceDiscontinued
POLYETHYLENE GLYCOL 3350 120GM/PACKET, POTASSIUM CHLORIDE 1.49GM/PACKET, SODIUM BICARBONATE 3.36GM/PACKET, SODIUM CHLORIDE 2.92GM/PACKET, SODIUM SULFATE ANHYDROUS 11.36GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SOLUTION · ORAL
COLYTE-FLAVORED · ReferenceDiscontinued
POLYETHYLENE GLYCOL 3350 227.1GM/BOT, POTASSIUM CHLORIDE 2.82GM/BOT, SODIUM BICARBONATE 6.36GM/BOT, SODIUM CHLORIDE 5.53GM/BOT, SODIUM SULFATE ANHYDROUS 21.5GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SOLUTION · ORAL
COLYTE · ReferenceDiscontinued
POLYETHYLENE GLYCOL 3350 360GM/PACKET, POTASSIUM CHLORIDE 4.47GM/PACKET, SODIUM BICARBONATE 10.08GM/PACKET, SODIUM CHLORIDE 8.76GM/PACKET, SODIUM SULFATE ANHYDROUS 34.08GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SOLUTION · ORAL
COLYTE WITH FLAVOR PACKS · ReferenceDiscontinued
POLYETHYLENE GLYCOL 3350 240GM/BOT, POTASSIUM CHLORIDE 2.98GM/BOT, SODIUM BICARBONATE 6.72GM/BOT, SODIUM CHLORIDE 5.84GM/BOT, SODIUM SULFATE ANHYDROUS 22.72GM/BOT · FOR SOLUTION · ORAL
COLYTE · 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SODIUM SULFATE ANHYDROUS 21.5GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SOLUTION · ORAL
COLYTE · ReferenceDiscontinued
POLYETHYLENE GLYCOL 3350 227.1GM/BOT, POTASSIUM CHLORIDE 2.82GM/BOT, SODIUM BICARBONATE 6.36GM/BOT, SODIUM CHLORIDE 5.53GM/BOT, SODIUM SULFATE ANHYDROUS 21.5GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SOLUTION · ORAL
Approval history
2013-04-24Manufacturing (CMC) · Supplement 45 · standardAP
2002-11-12Manufacturing (CMC) · Supplement 36 · standardAP
2002-05-16Manufacturing (CMC) · Supplement 34 · standardAP
2000-10-16Labeling · Supplement 30 · standardAP
2000-10-16Labeling · Supplement 31 · standardAP
2000-10-12Manufacturing (CMC) · Supplement 33 · standardAP
2000-07-20Manufacturing (CMC) · Supplement 32 · standardAP
1999-11-30Manufacturing (CMC) · Supplement 29 · standardAP
1999-07-21Manufacturing (CMC) · Supplement 28 · standardAP
1998-10-08Manufacturing (CMC) · Supplement 26 · standardAP
1998-04-17Manufacturing (CMC) · Supplement 27 · standardAP
1997-12-09Manufacturing (CMC) · Supplement 25 · standardAP
1997-01-21Manufacturing (CMC) · Supplement 24 · standardAP
1996-09-06Manufacturing (CMC) · Supplement 23 · standardAP
1996-01-24Manufacturing (CMC) · Supplement 22 · standardAP
1994-10-13Manufacturing (CMC) · Supplement 20 · standardAP
1994-06-06Manufacturing (CMC) · Supplement 18 · standardAP
1994-04-25Manufacturing (CMC) · Supplement 16 · standardAP
1994-04-25Manufacturing (CMC) · Supplement 15 · standardAP
1994-04-04Manufacturing (CMC) · Supplement 19 · standardAP
1994-02-24Manufacturing (CMC) · Supplement 17 · standardAP
1993-03-05Manufacturing (CMC) · Supplement 14 · standardAP
1991-11-14Manufacturing (CMC) · Supplement 11 · standardAP
1990-06-26Manufacturing (CMC) · Supplement 13 · standardAP
1989-01-31Labeling · Supplement 8AP
1989-01-31Manufacturing (CMC) · Supplement 7 · standardAP
1987-06-12Manufacturing (CMC) · Supplement 6 · standardAP
1986-08-19Manufacturing (CMC) · Supplement 5 · standardAP
1986-08-19Labeling · Supplement 1AP
1986-03-27Manufacturing (CMC) · Supplement 4 · standardAP
1984-10-26Type 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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