NDA 21892, held by Salix Pharms. Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate.
As of Nov 14, 2026, NDA 21892 (Osmoprep), held by Salix Pharms, was first approved by FDA on Mar 16, 2006, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 16, 2006 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Osmoprep0.398GM;1.102GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate | DiscontinuedReference drug |
| Nov 29, 2018 | Supplement 14Labeling · Standard review | Approved | |
| Jun 21, 2016 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Sep 15, 2015 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Oct 5, 2012 | Supplement 6Labeling · Standard review | Approved | |
| Dec 9, 2011 | Supplement 9REMS | Approved | |
| Oct 13, 2009 | Supplement 4Labeling · Standard review | Approved | |
| Mar 25, 2009 | Supplement 3Labeling | Approved | |
| Dec 10, 2008 | Supplement 2Labeling · Standard review | Approved | |
| Sep 18, 2007 | Supplement 1Labeling · Standard review | Approved | |
| Mar 16, 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
