NDA 21823, held by Warner Chilcott. Calcium Carbonate; Risedronate Sodium.
As of Nov 14, 2026, NDA 21823 (Actonel With Calcium (Copackaged)), held by Warner Chilcott, was first approved by FDA on Aug 12, 2005, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 12, 2005 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Actonel With Calcium (Copackaged)EQ 500MG BASE;35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Calcium Carbonate; Risedronate Sodium | DiscontinuedReference drug |
| Apr 8, 2015 | Supplement 11Labeling · Standard review | Approved | |
| Mar 26, 2015 | Supplement 10Labeling · Standard review | Approved | |
| Apr 19, 2013 | Supplement 9Labeling · Standard review | Approved | |
| Aug 22, 2011 | Supplement 8REMS | Approved | |
| Jan 25, 2011 | Supplement 6REMS | Approved | |
| Jan 25, 2011 | Supplement 7Labeling | Approved | |
| Aug 22, 2006 | Supplement 4Labeling · Standard review | Approved | |
| Jun 19, 2006 | Supplement 3Labeling · Standard review | Approved | |
| Jan 24, 2006 | Supplement 2Labeling · Standard review | Approved | |
| Aug 12, 2005 | Original applicationNew combination · 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
