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Last Updated: March 18, 2024

Details for New Drug Application (NDA): 018983


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NDA 018983 describes COLYTE-FLAVORED, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. Additional details are available on the COLYTE-FLAVORED profile page.

The generic ingredient in COLYTE-FLAVORED is polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous. There are four hundred and twenty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous profile page.

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;ORALStrength227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 26, 1984TE:RLD:No

Profile for product number 005

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;ORALStrength120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 26, 1984TE:RLD:No

Profile for product number 006

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;ORALStrength360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 26, 1984TE:RLD:No

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