NDA 21097, held by Salix Pharms. Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate.
As of Nov 14, 2026, NDA 21097 (Visicol), held by Salix Pharms, was first approved by FDA on Sep 21, 2000, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 21, 2000 | Original applicationTYPE 7 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Visicol0.398GM;1.102GM · tablet;oral | Sodium Phosphate, Dibasic, Anhydrous; Sodium Phosphate, Monobasic, Monohydrate | Discontinued |
| Mar 7, 2013 | Supplement 16Labeling · Standard review | Approved | |
| Dec 9, 2011 | Supplement 15REMS | Approved | |
| Oct 13, 2009 | Supplement 14Labeling · Standard review | Approved | |
| Mar 25, 2009 | Supplement 13Labeling | Approved | |
| Mar 31, 2006 | Supplement 10Labeling · Standard review | Approved | |
| Feb 10, 2005 | Supplement 7Labeling · Standard review | Approved | |
| Feb 10, 2005 | Supplement 9Manufacturing · Standard review | Approved | |
| Sep 4, 2002 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Mar 12, 2002 | Supplement 5Manufacturing · Standard review | Approved | |
| Sep 26, 2001 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Apr 2, 2001 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Mar 30, 2001 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Nov 22, 2000 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Sep 21, 2000 | Original applicationTYPE 7 · 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
