NDA 21881, held by Salix Pharms. Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate.
As of Nov 14, 2026, NDA 21881 (Moviprep), held by Salix Pharms, was first approved by FDA on Aug 2, 2006, with 11 approved supplements and 0 published complete response letters.
MoviPrep is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 2, 2006 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Moviprep4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM · for solution;oral | Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate | RxReference drug |
| Apr 6, 2022 | Supplement 24Labeling · Standard review | Approved | |
| May 14, 2021 | Supplement 23Labeling · Standard review | Approved | |
| Nov 5, 2019 | Supplement 20Labeling · Standard review | Approved | |
| Dec 7, 2018 | Supplement 17Labeling · Standard review | Approved | |
| Dec 17, 2013 | Supplement 16Labeling · Standard review | Approved | |
| Sep 12, 2013 | Supplement 15Labeling · Standard review | Approved | |
| Aug 29, 2012 | Supplement 12Labeling | Approved | |
| Apr 28, 2011 | Supplement 8Labeling · Standard review | Approved | |
| Nov 2, 2010 | Supplement 10Labeling | Approved | |
| Nov 20, 2008 | Supplement 4Labeling · Standard review | Approved | None posted |
| Feb 5, 2008 | Supplement 3Labeling · Standard review | Approved | |
| Aug 2, 2006 | Original applicationNew dosage form · Standard review | Approved |
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
