NDA 210880, held by Hetero Labs Unit Iii.
As of Nov 13, 2026, NDA 210880, held by Hetero Labs Unit Iii, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 8, 2018 | Original applicationNew combination ยท Priority 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