NDA 21311, held by Astrazeneca Pharms.
As of Nov 14, 2026, NDA 21311, held by Astrazeneca Pharms, was not approved, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 12, 2016 | Supplement 29Labeling ยท 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
