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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212379
Company: JOURNEY

Products on NDA 212379

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMZEEQ	MINOCYCLINE HYDROCHLORIDE	EQ 4% BASE	AEROSOL, FOAM;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212379

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/18/2019	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212379s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212379Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212379Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2022	SUPPL-7	Manufacturing (CMC)-Expiration Date	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212379Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212379Orig1s007ltr.pdf
01/29/2021	SUPPL-3	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212379s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212379Orig1s003ltr.pdf

Labels for NDA 212379

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2022	SUPPL-7	Manufacturing (CMC)-Expiration Date	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212379Orig1s007lbl.pdf
01/29/2021	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212379s003lbl.pdf
01/29/2021	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212379s003lbl.pdf
10/18/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212379s000lbl.pdf

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