Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022395
Company: AVERITAS
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 |
---|---|---|---|---|---|
07/31/2024 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022395s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022395Orig1s024ltr.pdf | |
02/17/2023 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022395s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022395Orig1s023ltr.pdf | |
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 |
---|---|---|---|---|---|
07/31/2024 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022395s024lbl.pdf | |
02/17/2023 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022395s023lbl.pdf | |
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 |