Home Applications 215064 Application 215064
Type NDA
Sponsor CHIESI Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FILSUVEZ BIRCH TRITERPENES GEL;TOPICAL 10% 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 N215064-001 FILSUVEZ BIRCH TRITERPENES 10% GEL / TOPICAL RLD, RS 2023-12-18
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215064-001 8828444 2027-06-21 Drug product 2024-02-16 N215064-001 9352041 2030-11-24 U-3811 2024-02-16 N215064-001 9827214 2030-11-24 U-3811 2024-02-16 N215064-001 11083733 2039-01-04 Drug product 2024-02-16 N215064-001 11266660 2039-01-04 U-3811 2024-02-16 N215064-001 12268695 2039-01-04 U-3811 2025-05-02
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215064-001 NCE 2028-12-18 N215064-001 ODE-460 2030-12-18
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.
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 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 90 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 N215064-001 8828444 2027-06-21 Drug product 2024-02-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215064-001 9352041 2030-11-24 U-3811 2024-02-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215064-001 9827214 2030-11-24 U-3811 2024-02-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215064-001 11083733 2039-01-04 Drug product 2024-02-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215064-001 11266660 2039-01-04 U-3811 2024-02-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215064-001 12268695 2039-01-04 U-3811 2025-05-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215064-001 8828444 2026-06-21 Drug product 2024-02-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215064-001 9352041 2030-11-24 U-3811 2024-02-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215064-001 9827214 2030-11-24 U-3811 2024-02-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215064-001 11083733 2039-01-04 Drug product 2024-02-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215064-001 11266660 2039-01-04 U-3811 2024-02-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215064-001 12268695 2039-01-04 U-3811 2025-05-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215064-001 8828444 2026-06-21 Drug product 2024-02-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215064-001 9352041 2030-11-24 U-3811 2024-02-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215064-001 9827214 2030-11-24 U-3811 2024-02-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215064-001 11083733 2039-01-04 Drug product 2024-02-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215064-001 11266660 2039-01-04 U-3811 2024-02-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215064-001 12268695 2039-01-04 U-3811 2025-05-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215064-001 8828444 2026-06-21 Drug product 2024-02-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215064-001 9352041 2030-11-24 U-3811 2024-02-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215064-001 9827214 2030-11-24 U-3811 2024-02-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215064-001 11083733 2039-01-04 Drug product 2024-02-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215064-001 11266660 2039-01-04 U-3811 2024-02-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215064-001 12268695 2039-01-04 U-3811 2025-05-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215064-001 8828444 2025-06-21 Drug product 2024-02-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215064-001 9352041 2030-11-24 U-3811 2024-02-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215064-001 9827214 2030-11-24 U-3811 2024-02-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215064-001 11083733 2039-01-04 Drug product 2024-02-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215064-001 11266660 2039-01-04 U-3811 2024-02-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215064-001 8828444 2025-06-21 Drug product 2024-02-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215064-001 9352041 2030-11-24 U-3811 2024-02-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215064-001 9827214 2030-11-24 U-3811 2024-02-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215064-001 11083733 2039-01-04 Drug product 2024-02-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215064-001 11266660 2039-01-04 U-3811 2024-02-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215064-001 8828444 2025-06-21 Drug product 2024-02-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215064-001 9352041 2030-11-24 U-3811 2024-02-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215064-001 9827214 2030-11-24 U-3811 2024-02-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215064-001 11083733 2039-01-04 Drug product 2024-02-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215064-001 11266660 2039-01-04 U-3811 2024-02-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215064-001 8828444 2025-06-21 Drug product 2024-02-16 2680178bc6a6…
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 · 2 matching rows.
Documents# Document, Submission type, Date table Document Submission type Date 77629 ORIG 2024-02-26 77205 ORIG 2024-01-11 77088 ORIG 2023-12-19