BLA 21878, held by Novo Nordisk. Insulin Detemir.
As of Nov 13, 2026, BLA 21878 (Levemir), held by Novo Nordisk, was first approved by FDA on Oct 19, 2005, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 19, 2005 | Original applicationTYPE 6 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levemir100 UNITS/ML · injectable; injection | Insulin Detemir | 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
