Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213690
Company: JOURNEY

Products on NDA 213690

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZILXI	MINOCYCLINE HYDROCHLORIDE	EQ 1.5% BASE	AEROSOL, FOAM;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213690

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/2020	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213690s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213690Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213690Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/20/2024	SUPPL-9		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213690Orig1s009lbl.pdf

Labels for NDA 213690

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/20/2024	SUPPL-9	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213690Orig1s009lbl.pdf
05/28/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213690s000lbl.pdf