FDA Orange Book
Generic for Colyte
Colyte contains polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride and sodium sulfate anhydrous. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Colyte is polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride and sodium sulfate anhydrous. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 1 of the 5 Colyte products the Orange Book lists.
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Colyte products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, oral | 120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET | Discontinued | None | 0 | None |
| for solution, oral | 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT | Discontinued | None | 0 | None |
| for solution, oral | 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET | Discontinued | None | 0 | None |
| for solution, oral | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT | Discontinued | None | 1 | None |
| for solution, oral | 360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET | Discontinued | None | 0 | None |
NDA 018983, held by STRIDES PHARMA INTERNATIONAL AG. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride and sodium sulfate anhydrous
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NOVEL LABORATORIES INC | 090186 | None (No TE code listed) | June 1, 2009 | 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/BOT;22.72GM/BOT |
Questions
Is there a generic for Colyte?
Yes. The generic name for Colyte is polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride and sodium sulfate anhydrous. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 1 of the 5 Colyte products the Orange Book lists.
What is the generic name for Colyte?
The active ingredient in Colyte is polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride and sodium sulfate anhydrous, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.