Colyte, Colyte-Flavored, Colyte With Flavor Packs

NDA 18983, held by Strides Pharma Intl. Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous.

As of Nov 13, 2026, NDA 18983 (Colyte, Colyte-Flavored, Colyte With Flavor Packs), held by Strides Pharma Intl, was first approved by FDA on Oct 26, 1984, with 34 approved supplements and 0 published complete response letters.

First approved: Oct 26, 1984
Review: Standard
Supplements approved: 34
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 35 submissions below

Date	Submission	Status	Documents
Oct 26, 1984	Original applicationNew combination · Standard review	Approved	None posted

Products

8 strengths and forms


Colyte227.1GM/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Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · for solution;oral	Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous	DiscontinuedReference drug
Colyte120GM/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Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · for solution;oral	Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous	DiscontinuedReference drug
Colyte360GM/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Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · for solution;oral	Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous	DiscontinuedReference drug
Colyte240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · for solution;oral	Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous	DiscontinuedReference drug
Colyte-Flavored227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · for solution;oral	Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous	DiscontinuedReference drug
Colyte-Flavored240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · for solution;oral	Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous	DiscontinuedReference drug
Colyte227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · for solution;oral	Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous	DiscontinuedReference drug
Colyte With Flavor Packs240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT · for solution;oral	Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous	DiscontinuedReference drug

All 35 submissions, including labeling and manufacturing supplements


May 14, 2021	Supplement 51Labeling · Standard review	Approved	Label Letter
Aug 19, 2013	Supplement 47Labeling · Standard review	Approved	Letter Label
Apr 24, 2013	Supplement 45Manufacturing · Standard review	Approved	None posted
Oct 23, 2003	Supplement 37Labeling · Standard review	Approved	Letter
Nov 12, 2002	Supplement 36Manufacturing · Standard review	Approved	None posted
Sep 16, 2002	Supplement 35Labeling · Standard review	Approved	Letter
May 16, 2002	Supplement 34Manufacturing · Standard review	Approved	None posted
Oct 16, 2000	Supplement 31Labeling · Standard review	Approved	None posted
Oct 16, 2000	Supplement 30Labeling · Standard review	Approved	None posted
Oct 12, 2000	Supplement 33Manufacturing · Standard review	Approved	None posted
Jul 20, 2000	Supplement 32Manufacturing · Standard review	Approved	None posted
Nov 30, 1999	Supplement 29Manufacturing · Standard review	Approved	None posted
Jul 21, 1999	Supplement 28Manufacturing · Standard review	Approved	None posted
Oct 8, 1998	Supplement 26Manufacturing · Standard review	Approved	None posted
Apr 17, 1998	Supplement 27Manufacturing · Standard review	Approved	None posted
Dec 9, 1997	Supplement 25Manufacturing · Standard review	Approved	None posted
Jan 21, 1997	Supplement 24Manufacturing · Standard review	Approved	None posted
Sep 6, 1996	Supplement 23Manufacturing · Standard review	Approved	None posted
Jan 24, 1996	Supplement 22Manufacturing · Standard review	Approved	None posted
Oct 13, 1994	Supplement 20Manufacturing · Standard review	Approved	None posted
Jun 6, 1994	Supplement 18Manufacturing · Standard review	Approved	None posted
Apr 25, 1994	Supplement 16Manufacturing · Standard review	Approved	None posted
Apr 25, 1994	Supplement 15Manufacturing · Standard review	Approved	None posted
Apr 4, 1994	Supplement 19Manufacturing · Standard review	Approved	None posted
Feb 24, 1994	Supplement 17Manufacturing · Standard review	Approved	None posted
Mar 5, 1993	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 14, 1991	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 26, 1990	Supplement 13Manufacturing · Standard review	Approved	None posted
Jan 31, 1989	Supplement 8Labeling	Approved	None posted
Jan 31, 1989	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 12, 1987	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 19, 1986	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 19, 1986	Supplement 1Labeling	Approved	None posted
Mar 27, 1986	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 26, 1984	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 18983
Drugs@FDA: Overview at FDA
Company: Strides Pharma International

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters