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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022395
Company: AVERITAS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUTENZA CAPSAICIN 8% PATCH;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
11/16/2009 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022395lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022395s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022395_qutenza_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022395s000Sumr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/11/2022 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022395s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022395Orig1s021ltr.pdf
08/05/2021 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022395s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022395Orig1s020ltr.pdf
07/17/2020 SUPPL-19 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022395s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022395Orig1s019ltr.pdf
05/28/2020 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022395s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022395Orig1s018ltr.pdf
02/24/2016 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/21/2015 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/14/2012 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/11/2022 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022395s021lbl.pdf
08/05/2021 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022395s020lbl.pdf
07/17/2020 SUPPL-19 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022395s019lbl.pdf
05/28/2020 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022395s018lbl.pdf
11/16/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022395lbl.pdf
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