NDA 208656, held by Micro Labs Ltd.
As of Nov 13, 2026, NDA 208656, held by Micro Labs Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 28, 2017 | Original applicationNew dosage form ยท Standard review | Tentative approval |
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