← FDA DRUG APPROVALS

FDA NDA · NDA022395

QUTENZA

capsaicin

Sponsor: AVERITAS

APPLICATION
NDA022395
TYPE
NDA
ORIGINAL APPROVAL
2009-11-16
LATEST ACTION
2024-07-31
ROUTE
TOPICAL
DOSAGE FORM
PATCH
MARKETING STATUS
Prescription

Products

QUTENZA · ReferencePrescription
CAPSAICIN 8% · PATCH · TOPICAL

Approval history

2024-07-31Labeling · Supplement 24 · standard — Letter ↗AP
2023-02-17Labeling · Supplement 23 · standard — Letter ↗AP
2022-08-11Labeling · Supplement 21 · standard — Letter ↗AP
2021-08-05Labeling · Supplement 20 · standard — Label ↗AP
2020-07-17Efficacy · Supplement 19 · standard — Letter ↗AP
2020-05-28Labeling · Supplement 18 · standard — Label ↗AP
2016-02-24Manufacturing (CMC) · Supplement 16 · standardAP
2015-05-21Manufacturing (CMC) · Supplement 15 · standardAP
2012-12-14Manufacturing (CMC) · Supplement 14 · standardAP
2009-11-16Type 1 - New Molecular Entity · Original · standard — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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