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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022395
Company: AVERITAS

Summary Review

Products on NDA 022395

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QUTENZA	CAPSAICIN	8%	PATCH;TOPICAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022395

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
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.

Labels for NDA 022395

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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

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