Application 213005

Type
NDA
Sponsor
Liquidia Technologies, Inc.

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001YUTREPIATREPROSTINIL SODIUMPOWDER;INHALATIONEQ 0.0265MG BASE/INHYesYes
002YUTREPIATREPROSTINIL SODIUMPOWDER;INHALATIONEQ 0.053MG BASE/INHYesYes
003YUTREPIATREPROSTINIL SODIUMPOWDER;INHALATIONEQ 0.0795MG BASE/INHYesYes
004YUTREPIATREPROSTINIL SODIUMPOWDER;INHALATIONEQ 0.106MG BASE/INHYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N213005-001YUTREPIATREPROSTINIL SODIUMEQ 0.0265MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23
N213005-002YUTREPIATREPROSTINIL SODIUMEQ 0.053MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23
N213005-003YUTREPIATREPROSTINIL SODIUMEQ 0.0795MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23
N213005-004YUTREPIATREPROSTINIL SODIUMEQ 0.106MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N213005-001108984942037-05-05U-42002025-06-13
N213005-001116603042037-05-05U-42002025-06-13
N213005-001117124422037-05-05U-42002025-06-13
N213005-001117448352037-05-05Drug product2025-06-13
N213005-001117448362037-05-05Drug product2025-06-13
N213005-001123904752037-05-05Drug product2025-08-29
N213005-002108984942037-05-05U-42002025-06-13
N213005-002116603042037-05-05U-42002025-06-13
N213005-002117124422037-05-05U-42002025-06-13
N213005-002117448352037-05-05Drug product2025-06-13
N213005-002117448362037-05-05Drug product2025-06-13
N213005-002123904752037-05-05Drug product2025-08-29
N213005-003108984942037-05-05U-42002025-06-13
N213005-003116603042037-05-05U-42002025-06-13
N213005-003117124422037-05-05U-42002025-06-13
N213005-003117448352037-05-05Drug product2025-06-13
N213005-003117448362037-05-05Drug product2025-06-13
N213005-003123904752037-05-05Drug product2025-08-29
N213005-004108984942037-05-05U-42002025-06-13
N213005-004116603042037-05-05U-42002025-06-13
N213005-004117124422037-05-05U-42002025-06-13
N213005-004117448352037-05-05Drug product2025-06-13
N213005-004117448362037-05-05Drug product2025-06-13
N213005-004123904752037-05-05Drug product2025-08-29

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N213005-001NP2028-05-23
N213005-002NP2028-05-23
N213005-003NP2028-05-23
N213005-004NP2028-05-23

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N213005-001YUTREPIAEQ 0.0265MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23a50c72e98297…
2026-08-01 22:54:322026-06N213005-002YUTREPIAEQ 0.053MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23a50c72e98297…
2026-08-01 22:54:322026-06N213005-003YUTREPIAEQ 0.0795MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23a50c72e98297…
2026-08-01 22:54:322026-06N213005-004YUTREPIAEQ 0.106MG BASE/INHPOWDER / INHALATIONRLD, RS2025-05-23a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N213005-001108984942037-05-05U-42002025-06-13a50c72e98297…
2026-08-01 22:54:322026-06N213005-001116603042037-05-05U-42002025-06-13a50c72e98297…
2026-08-01 22:54:322026-06N213005-001117124422037-05-05U-42002025-06-13a50c72e98297…
2026-08-01 22:54:322026-06N213005-001117448352037-05-05Drug product2025-06-13a50c72e98297…
2026-08-01 22:54:322026-06N213005-001117448362037-05-05Drug product2025-06-13a50c72e98297…
2026-08-01 22:54:322026-06N213005-001123904752037-05-05Drug product2025-08-29a50c72e98297…
2026-08-01 22:54:322026-06N213005-002108984942037-05-05U-42002025-06-13a50c72e98297…
2026-08-01 22:54:322026-06N213005-002116603042037-05-05U-42002025-06-13a50c72e98297…
2026-08-01 22:54:322026-06N213005-002117124422037-05-05U-42002025-06-13a50c72e98297…
2026-08-01 22:54:322026-06N213005-002117448352037-05-05Drug product2025-06-13a50c72e98297…
2026-08-01 22:54:322026-06N213005-002117448362037-05-05Drug product2025-06-13a50c72e98297…
2026-08-01 22:54:322026-06N213005-002123904752037-05-05Drug product2025-08-29a50c72e98297…
2026-08-01 22:54:322026-06N213005-003108984942037-05-05U-42002025-06-13a50c72e98297…
2026-08-01 22:54:322026-06N213005-003116603042037-05-05U-42002025-06-13a50c72e98297…
2026-08-01 22:54:322026-06N213005-003117124422037-05-05U-42002025-06-13a50c72e98297…
2026-08-01 22:54:322026-06N213005-003117448352037-05-05Drug product2025-06-13a50c72e98297…
2026-08-01 22:54:322026-06N213005-003117448362037-05-05Drug product2025-06-13a50c72e98297…
2026-08-01 22:54:322026-06N213005-003123904752037-05-05Drug product2025-08-29a50c72e98297…
2026-08-01 22:54:322026-06N213005-004108984942037-05-05U-42002025-06-13a50c72e98297…
2026-08-01 22:54:322026-06N213005-004116603042037-05-05U-42002025-06-13a50c72e98297…
2026-08-01 22:54:322026-06N213005-004117124422037-05-05U-42002025-06-13a50c72e98297…
2026-08-01 22:54:322026-06N213005-004117448352037-05-05Drug product2025-06-13a50c72e98297…
2026-08-01 22:54:322026-06N213005-004117448362037-05-05Drug product2025-06-13a50c72e98297…
2026-08-01 22:54:322026-06N213005-004123904752037-05-05Drug product2025-08-29a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N213005-001NP2028-05-23a50c72e98297…
2026-08-01 22:54:322026-06N213005-002NP2028-05-23a50c72e98297…
2026-08-01 22:54:322026-06N213005-003NP2028-05-23a50c72e98297…
2026-08-01 22:54:322026-06N213005-004NP2028-05-23a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YutrepiaTREPROSTINILLiquidia Technologies, Inc.e8f6d534-115c-440e-bdbb-b443a29bb4682025-09-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 213005
application number: NDA213005

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82398ORIG 2025-06-02
69267ORIG2021-11-05