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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201922
Company: JOURNEY

Summary Review

Products on NDA 201922

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201922

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.cfm 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
08/13/2015	SUPPL-2	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201922s002lbl.pdf

Labels for NDA 201922

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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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