FDA approval · Drugs@FDA
COLYTE-FLAVOREDpolyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride, sodium sulfate anhydrous
NDA018983 ·
FDA approved the original new drug application for COLYTE-FLAVORED on October 26, 1984, sponsored by STRIDES PHARMA INTL. FDA marks all 8 products under the application discontinued. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- NDA018983
- Sponsor
- STRIDES PHARMA INTL
- Original approval
- Review
- standard review
- Submission class
- Type 4 - New Combination
- Active ingredient
- polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride, sodium sulfate anhydrous
Browse every approval whose brand starts with C, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| 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5.84GM/BOT; sodium sulfate anhydrous 22.72GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION | ORAL | Discontinued |
| 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5.84GM/BOT; sodium sulfate anhydrous 22.72GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION | ORAL | Discontinued |
| 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sodium sulfate anhydrous 11.36GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION | ORAL | Discontinued |
| 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5.53GM/BOT; sodium sulfate anhydrous 21.5GM/BOT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION | ORAL | Discontinued |
| 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 | Discontinued |
| 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 | Discontinued |
| 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 | Discontinued |
| 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 | Discontinued |
What “discontinued” means in FDA’s record
Drugs@FDA marks a product discontinued when it was never marketed, when it has been taken off the market, when it is made only for export, when it is made for military use, or when its approval was withdrawn for a reason other than safety or effectiveness. The record does not say which of those applies to a given product. The word on its own is not evidence that FDA found the drug unsafe.
Source: FDA, Drugs@FDA glossary of terms, under “Discontinued Drug Product”.
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
FDA’s record shows no approved efficacy supplement on this application.
FDA records other approved supplements on this application, by the class code it assigns them: Manufacturing (CMC) 26 · Labeling 8. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to STRIDES PHARMA INTL
An approval date is the start of the question, not the end
What a drug is worth to the company that owns it depends on what else is in the pipeline, how much cash is behind it and who else is running the same trial. FuzeBio reads a biotech end to end on demand — pipeline in plain English, trial design and endpoints, competitors, the cash position, and a valuation with its assumptions on the page. Moderna’s report is open in full, no account.
Open the Moderna reportA complete sample report — nothing held back, no sign-up.