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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022572
Company: MOBIUS THERAP

Summary Review

Products on NDA 022572

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MITOSOL	MITOMYCIN	0.2MG/VIAL	FOR SOLUTION;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022572

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/07/2012	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022572s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022572s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022572_mitosol_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022572Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/23/2021	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022572s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022572Orig1s009ltr.pdf
08/07/2020	SUPPL-8	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022572s008lbl.pdf
12/22/2017	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022572s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022572Orig1s005ltr.pdf
01/20/2016	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022572s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022572Orig1s004ltr.pdf
09/25/2014	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022572s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022572Orig1s003ltr.pdf

Labels for NDA 022572

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/23/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022572s009lbl.pdf
08/07/2020	SUPPL-8	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022572s008lbl.pdf
12/22/2017	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022572s005lbl.pdf
01/20/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022572s004lbl.pdf
09/25/2014	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022572s003lbl.pdf
02/07/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022572s000lbl.pdf

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