Home Applications 217865 Application 217865
Type NDA
Sponsor ITALFARMACO SPA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DUVYZAT GIVINOSTAT HYDROCHLORIDE SUSPENSION;ORAL EQ 8.86MG BASE/ML 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 N217865-001 DUVYZAT GIVINOSTAT HYDROCHLORIDE EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217865-001 7329689 2027-01-15 Drug substance, Drug product 2024-04-19 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 N217865-001 10688047 2036-10-28 U-3885 Drug product 2024-04-19 N217865-001 12606519 2040-05-03 Drug substance, Drug product 2026-05-07
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217865-001 NCE 2029-03-21 N217865-001 ODE-473 2031-03-21
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 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217865-001 DUVYZAT EQ 8.86MG BASE/ML SUSPENSION / ORAL RLD, RS 2024-03-21 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 66 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 N217865-001 7329689 2027-01-15 Drug substance, Drug product 2024-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217865-001 10688047 2036-10-28 U-3885 Drug product 2024-04-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217865-001 12606519 2040-05-03 Drug substance, Drug product 2026-05-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217865-001 7329689 2027-01-15 Drug substance, Drug product 2024-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217865-001 10688047 2036-10-28 U-3885 Drug product 2024-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217865-001 7329689 2026-01-15 Drug substance, Drug product 2024-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217865-001 10688047 2036-10-28 U-3885 Drug product 2024-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217865-001 7329689 2026-01-15 Drug substance, Drug product 2024-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217865-001 10688047 2036-10-28 U-3885 Drug product 2024-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217865-001 7329689 2026-01-15 Drug substance, Drug product 2024-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217865-001 10688047 2036-10-28 U-3885 Drug product 2024-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217865-001 7329689 2026-01-15 Drug substance, Drug product 2024-04-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217865-001 10688047 2036-10-28 U-3885 Drug product 2024-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217865-001 7329689 2026-01-15 Drug substance, Drug product 2024-04-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217865-001 10688047 2036-10-28 U-3885 Drug product 2024-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217865-001 7329689 2025-01-15 Drug substance, Drug product 2024-04-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217865-001 10688047 2036-10-28 U-3885 Drug product 2024-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217865-001 7329689 2025-01-15 Drug substance, Drug product 2024-04-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217865-001 10688047 2036-10-28 U-3885 Drug product 2024-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217865-001 7329689 2025-01-15 Drug substance, Drug product 2024-04-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217865-001 9421184 2032-02-03 U-3885 2024-04-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217865-001 9867799 2032-02-03 U-3885 2024-04-19 d8e5a09893c0…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DUVYZAT GIVINOSTAT Italfarmaco SPA 1a28a3db-7880-4ac2-a2f2-2b4e362aafb6 2024-11-21 Warnings, Adverse reactions Exact identifier application applno (NDA): 217865 application number: NDA217865
Documents# Document, Submission type, Date table Document Submission type Date 78334 ORIG 2024-05-02 77923 ORIG 2024-03-22 77920 ORIG 2024-03-22