Home Applications 219019 Application 219019
Type NDA
Sponsor GENZYME CORP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 QFITLIA FITUSIRAN SODIUM SOLUTION;SUBCUTANEOUS EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML) Yes Yes 002 QFITLIA FITUSIRAN SODIUM SOLUTION;SUBCUTANEOUS EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219019-001 QFITLIA FITUSIRAN SODIUM EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-03-28 N219019-002 QFITLIA FITUSIRAN SODIUM EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-03-28
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 N219019-001 9376680 2033-03-15 U-4165 Drug substance, Drug product 2025-04-17 N219019-001 9127274 2033-03-22 U-4165 Drug substance, Drug product 2025-04-17 N219019-001 11091759 2036-12-07 U-4165 2025-04-17 N219019-002 9376680 2033-03-15 U-4165 Drug substance, Drug product 2025-04-17 N219019-002 9127274 2033-03-22 U-4165 Drug substance, Drug product 2025-04-17 N219019-002 11091759 2036-12-07 U-4165 2025-04-17
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 matching rows.
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 2026-02-19 14:30 UTC 2026-02 N219019-001 QFITLIA EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219019-002 QFITLIA EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219019-001 QFITLIA EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219019-002 QFITLIA EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219019-001 QFITLIA EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219019-002 QFITLIA EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-03-28 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219019-001 QFITLIA EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-03-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219019-002 QFITLIA EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML) SOLUTION / SUBCUTANEOUS RLD, RS 2025-03-28 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N219019-001 9376680 2033-03-15 U-4165 Drug substance, Drug product 2025-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219019-001 9127274 2033-03-22 U-4165 Drug substance, Drug product 2025-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219019-001 11091759 2036-12-07 U-4165 2025-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219019-002 9376680 2033-03-15 U-4165 Drug substance, Drug product 2025-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219019-002 9127274 2033-03-22 U-4165 Drug substance, Drug product 2025-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219019-002 11091759 2036-12-07 U-4165 2025-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219019-001 9376680 2033-03-15 U-4165 Drug substance, Drug product 2025-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219019-001 9127274 2033-03-22 U-4165 Drug substance, Drug product 2025-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219019-001 11091759 2036-12-07 U-4165 2025-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219019-002 9376680 2033-03-15 U-4165 Drug substance, Drug product 2025-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219019-002 9127274 2033-03-22 U-4165 Drug substance, Drug product 2025-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219019-002 11091759 2036-12-07 U-4165 2025-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219019-001 9376680 2033-03-15 U-4165 Drug substance, Drug product 2025-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219019-001 9127274 2033-03-22 U-4165 Drug substance, Drug product 2025-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219019-001 11091759 2036-12-07 U-4165 2025-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219019-002 9376680 2033-03-15 U-4165 Drug substance, Drug product 2025-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219019-002 9127274 2033-03-22 U-4165 Drug substance, Drug product 2025-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219019-002 11091759 2036-12-07 U-4165 2025-04-17 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219019-001 9376680 2033-03-15 U-4165 Drug substance, Drug product 2025-04-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219019-001 9127274 2033-03-22 U-4165 Drug substance, Drug product 2025-04-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219019-001 11091759 2036-12-07 U-4165 2025-04-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219019-002 9376680 2033-03-15 U-4165 Drug substance, Drug product 2025-04-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219019-002 9127274 2033-03-22 U-4165 Drug substance, Drug product 2025-04-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219019-002 11091759 2036-12-07 U-4165 2025-04-17 a50c72e98297…
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 Qfitlia FITUSIRAN Genzyme Corporation 6dd2f8ac-6f90-4cbf-b197-97d74964135c 2025-09-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 219019 application number: NDA219019
Documents# Document, Submission type, Date table Document Submission type Date 81819 ORIG 2026-03-02 82174 ORIG 2025-05-14 81899 ORIG 2025-04-09 81818 ORIG 2025-04-03