NDA 201922, held by Journey. Minocycline Hydrochloride.
As of Nov 13, 2026, NDA 201922 (Ximino), held by Journey, was first approved by FDA on Jul 11, 2012, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 11, 2012 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| XiminoEQ 45MG BASE · capsule, extended release;oral | Minocycline Hydrochloride | Discontinued |
| XiminoEQ 67.5MG BASE · capsule, extended release;oral | Minocycline Hydrochloride | Discontinued |
| XiminoEQ 90MG BASE · capsule, extended release;oral | Minocycline Hydrochloride | Discontinued |
| XiminoEQ 112.5MG BASE · capsule, extended release;oral | Minocycline Hydrochloride | Discontinued |
| XiminoEQ 135MG BASE · capsule, extended release;oral | Minocycline Hydrochloride | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 29, 2026 | Supplement 4Labeling · Standard review | Approved | |
| Aug 13, 2015 | Supplement 2Manufacturing · Standard review | Approved | |
| Jul 11, 2012 | Original applicationNew dosage form · 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
