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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
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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