NDA 22138, held by Sanofi Aventis US. Enoxaparin Sodium.
As of Nov 13, 2026, NDA 22138 (Lovenox), held by Sanofi Aventis US, was first approved by FDA on May 16, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 16, 2007 | Original applicationTYPE 6 · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lovenox100MG/ML · injectable; injection | Enoxaparin Sodium | Rx |
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
