NDA 20707, held by Sanofi Aventis US. Tiludronate Disodium.
As of Nov 14, 2026, NDA 20707 (Skelid), held by Sanofi Aventis US, was first approved by FDA on Mar 7, 1997, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 7, 1997 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| SkelidEQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Tiludronate Disodium | DiscontinuedReference drug |
| Mar 19, 2010 | Supplement 6Labeling · Standard review | Approved | |
| Nov 17, 2006 | Supplement 5Labeling · Standard review | Approved | |
| Aug 21, 2003 | Supplement 4Labeling · Standard review | Approved | |
| Jun 3, 1998 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Mar 7, 1997 | Original applicationNew molecular entity · 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
