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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201922
Company: JOURNEY

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XIMINO MINOCYCLINE HYDROCHLORIDE EQ 45MG BASE CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
XIMINO MINOCYCLINE HYDROCHLORIDE EQ 67.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
XIMINO MINOCYCLINE HYDROCHLORIDE EQ 90MG BASE CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
XIMINO MINOCYCLINE HYDROCHLORIDE EQ 112.5MG BASE CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
XIMINO MINOCYCLINE HYDROCHLORIDE EQ 135MG BASE CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/11/2012 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201922s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201922Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201922_ximino_toc.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201922Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/29/2026 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/201922s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/201922Orig1s004ltr.pdf
08/13/2015 SUPPL-2 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201922s002lbl.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/29/2026 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/201922s004lbl.pdf
08/13/2015 SUPPL-2 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201922s002lbl.pdf
07/11/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201922s000lbl.pdf
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