Home Applications 213005 Application 213005
Type NDA
Sponsor Liquidia Technologies, Inc. Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 YUTREPIA TREPROSTINIL SODIUM POWDER;INHALATION EQ 0.0265MG BASE/INH Yes Yes 002 YUTREPIA TREPROSTINIL SODIUM POWDER;INHALATION EQ 0.053MG BASE/INH Yes Yes 003 YUTREPIA TREPROSTINIL SODIUM POWDER;INHALATION EQ 0.0795MG BASE/INH Yes Yes 004 YUTREPIA TREPROSTINIL SODIUM POWDER;INHALATION EQ 0.106MG BASE/INH Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213005-001 YUTREPIA TREPROSTINIL SODIUM EQ 0.0265MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 N213005-002 YUTREPIA TREPROSTINIL SODIUM EQ 0.053MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 N213005-003 YUTREPIA TREPROSTINIL SODIUM EQ 0.0795MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 N213005-004 YUTREPIA TREPROSTINIL SODIUM EQ 0.106MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23
Orange Book patents# Current patent rows page 1 of 1 · 24 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 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 2026-08-01 22:54:32 2026-06 N213005-001 YUTREPIA EQ 0.0265MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-002 YUTREPIA EQ 0.053MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-003 YUTREPIA EQ 0.0795MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-004 YUTREPIA EQ 0.106MG BASE/INH POWDER / INHALATION RLD, RS 2025-05-23 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 2026-08-01 22:54:32 2026-06 N213005-001 10898494 2037-05-05 U-4200 2025-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-001 11660304 2037-05-05 U-4200 2025-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-001 11712442 2037-05-05 U-4200 2025-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-001 11744835 2037-05-05 Drug product 2025-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-001 11744836 2037-05-05 Drug product 2025-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-001 12390475 2037-05-05 Drug product 2025-08-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-002 10898494 2037-05-05 U-4200 2025-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-002 11660304 2037-05-05 U-4200 2025-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-002 11712442 2037-05-05 U-4200 2025-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-002 11744835 2037-05-05 Drug product 2025-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-002 11744836 2037-05-05 Drug product 2025-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-002 12390475 2037-05-05 Drug product 2025-08-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-003 10898494 2037-05-05 U-4200 2025-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-003 11660304 2037-05-05 U-4200 2025-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-003 11712442 2037-05-05 U-4200 2025-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-003 11744835 2037-05-05 Drug product 2025-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-003 11744836 2037-05-05 Drug product 2025-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-003 12390475 2037-05-05 Drug product 2025-08-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-004 10898494 2037-05-05 U-4200 2025-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-004 11660304 2037-05-05 U-4200 2025-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-004 11712442 2037-05-05 U-4200 2025-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-004 11744835 2037-05-05 Drug product 2025-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-004 11744836 2037-05-05 Drug product 2025-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-004 12390475 2037-05-05 Drug product 2025-08-29 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-01 22:54:32 2026-06 N213005-001 NP 2028-05-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-002 NP 2028-05-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-003 NP 2028-05-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N213005-004 NP 2028-05-23 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 Yutrepia TREPROSTINIL Liquidia Technologies, Inc. e8f6d534-115c-440e-bdbb-b443a29bb468 2025-09-08 Warnings, Adverse reactions Exact identifier application applno (NDA): 213005 application number: NDA213005
Documents# Document, Submission type, Date table Document Submission type Date 82398 ORIG 2025-06-02 69267 ORIG 2021-11-05