Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
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
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English