Home Applications 022395 Application 022395
Type NDA
Sponsor AVERITAS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 QUTENZA CAPSAICIN PATCH;TOPICAL 8% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022395-001 QUTENZA CAPSAICIN 8% PATCH / TOPICAL RLD, RS 2009-11-16
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022395-001 9226903 2028-12-15 Drug product 2020-01-08 N022395-001 8821920 2030-03-26 Drug product 2020-01-08
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022395-001 QUTENZA 8% PATCH / TOPICAL RLD, RS 2009-11-16 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 5 · 196 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022395-001 10034841 2025-09-06 Drug product 2020-01-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022395-001 9226903 2028-12-15 Drug product 2020-01-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022395-001 8821920 2030-03-26 Drug product 2020-01-08 1e350fbaab3a…
Observed Orange Book exclusivity history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10144-928 Qutenza capsaicin Acorda Therapeutics, Inc. NDA Current 10144-929 Qutenza capsaicin Acorda Therapeutics, Inc. NDA Current 72512-928 Qutenza capsaicin Averitas Pharma Inc NDA Current 72512-928 Qutenza capsaicin Averitas Pharma Inc NDA Current 72512-928 Qutenza capsaicin Averitas Pharma Inc NDA Current 72512-928 Qutenza capsaicin Averitas Pharma Inc NDA Current 72512-929 Qutenza capsaicin Averitas Pharma Inc NDA Current 72512-929 Qutenza capsaicin Averitas Pharma Inc NDA Current 72512-929 Qutenza capsaicin Averitas Pharma Inc NDA Current 72512-929 Qutenza capsaicin Averitas Pharma Inc NDA Current 72512-930 Qutenza capsaicin Averitas Pharma Inc NDA Current 72512-930 Qutenza capsaicin Averitas Pharma Inc NDA Current