NDA 204553, held by Gator Pharms. Magnesium Sulfate; Potassium Sulfate; Sodium Sulfate.
As of Nov 14, 2026, NDA 204553 (Colprep Kit), held by Gator Pharms, was first approved by FDA on Dec 27, 2016, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 27, 2016 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Colprep Kit1.6GM/BOT;3.13GM/BOT;17.5GM/BOT · powder;oral | Magnesium Sulfate; Potassium Sulfate; Sodium Sulfate | DiscontinuedReference drug |
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
