NDA 209269, held by Epi Hlth. Minocycline Hydrochloride.
As of Nov 13, 2026, NDA 209269 (Minolira), held by Epi Hlth, was first approved by FDA on May 8, 2017, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 8, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| MinoliraEQ 105MG BASE · tablet, extended release;oral | Minocycline Hydrochloride | Discontinued |
| MinoliraEQ 135MG BASE · tablet, extended release;oral | Minocycline Hydrochloride | Discontinued |
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
