Drugs@FDA: FDA-Approved Drugs

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