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FDA NDA · NDA201922

XIMINO

Sponsor: JOURNEY

APPLICATION
NDA201922
TYPE
NDA
ORIGINAL APPROVAL
2012-07-11
LATEST ACTION
2026-01-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

XIMINODiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 112.5MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
XIMINODiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 67.5MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
XIMINODiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 135MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
XIMINODiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 90MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
XIMINODiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 45MG BASE · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2026-01-29Labeling · Supplement 4 · standard — Letter ↗AP
2015-08-13Manufacturing (CMC) · Supplement 2 · standard — Label ↗AP
2012-07-11Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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