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 42.

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	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.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213005-001	10898494	2037-05-05	U-4200		2025-06-13
N213005-001	11660304	2037-05-05	U-4200		2025-06-13
N213005-001	11712442	2037-05-05	U-4200		2025-06-13
N213005-001	11744835	2037-05-05		Drug product	2025-06-13
N213005-001	11744836	2037-05-05		Drug product	2025-06-13
N213005-001	12390475	2037-05-05		Drug product	2025-08-29
N213005-002	10898494	2037-05-05	U-4200		2025-06-13
N213005-002	11660304	2037-05-05	U-4200		2025-06-13
N213005-002	11712442	2037-05-05	U-4200		2025-06-13
N213005-002	11744835	2037-05-05		Drug product	2025-06-13
N213005-002	11744836	2037-05-05		Drug product	2025-06-13
N213005-002	12390475	2037-05-05		Drug product	2025-08-29
N213005-003	10898494	2037-05-05	U-4200		2025-06-13
N213005-003	11660304	2037-05-05	U-4200		2025-06-13
N213005-003	11712442	2037-05-05	U-4200		2025-06-13
N213005-003	11744835	2037-05-05		Drug product	2025-06-13
N213005-003	11744836	2037-05-05		Drug product	2025-06-13
N213005-003	12390475	2037-05-05		Drug product	2025-08-29
N213005-004	10898494	2037-05-05	U-4200		2025-06-13
N213005-004	11660304	2037-05-05	U-4200		2025-06-13
N213005-004	11712442	2037-05-05	U-4200		2025-06-13
N213005-004	11744835	2037-05-05		Drug product	2025-06-13
N213005-004	11744836	2037-05-05		Drug product	2025-06-13
N213005-004	12390475	2037-05-05		Drug product	2025-08-29

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213005-001	NP	2028-05-23
N213005-002	NP	2028-05-23
N213005-003	NP	2028-05-23
N213005-004	NP	2028-05-23

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N213005-001	YUTREPIA	EQ 0.0265MG BASE/INH	POWDER / INHALATION	RLD, RS	2025-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-002	YUTREPIA	EQ 0.053MG BASE/INH	POWDER / INHALATION	RLD, RS	2025-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-003	YUTREPIA	EQ 0.0795MG BASE/INH	POWDER / INHALATION	RLD, RS	2025-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-004	YUTREPIA	EQ 0.106MG BASE/INH	POWDER / INHALATION	RLD, RS	2025-05-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213005-001	YUTREPIA	EQ 0.0265MG BASE/INH	POWDER / INHALATION	RLD, RS	2025-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-002	YUTREPIA	EQ 0.053MG BASE/INH	POWDER / INHALATION	RLD, RS	2025-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-003	YUTREPIA	EQ 0.0795MG BASE/INH	POWDER / INHALATION	RLD, RS	2025-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-004	YUTREPIA	EQ 0.106MG BASE/INH	POWDER / INHALATION	RLD, RS	2025-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213005-001	YUTREPIA	EQ 0.0265MG BASE/INH	POWDER / INHALATION	RLD, RS	2025-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213005-002	YUTREPIA	EQ 0.053MG BASE/INH	POWDER / INHALATION	RLD, RS	2025-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213005-003	YUTREPIA	EQ 0.0795MG BASE/INH	POWDER / INHALATION	RLD, RS	2025-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213005-004	YUTREPIA	EQ 0.106MG BASE/INH	POWDER / INHALATION	RLD, RS	2025-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213005-001	YUTREPIA	EQ 0.0265MG BASE/INH	POWDER / INHALATION	RLD, RS	2025-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213005-002	YUTREPIA	EQ 0.053MG BASE/INH	POWDER / INHALATION	RLD, RS	2025-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213005-003	YUTREPIA	EQ 0.0795MG BASE/INH	POWDER / INHALATION	RLD, RS	2025-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213005-004	YUTREPIA	EQ 0.106MG BASE/INH	POWDER / INHALATION	RLD, RS	2025-05-23	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213005-001	YUTREPIA	EQ 0.0265MG BASE/INH	POWDER / INHALATION	RLD, RS	2025-05-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213005-002	YUTREPIA	EQ 0.053MG BASE/INH	POWDER / INHALATION	RLD, RS	2025-05-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213005-003	YUTREPIA	EQ 0.0795MG BASE/INH	POWDER / INHALATION	RLD, RS	2025-05-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213005-004	YUTREPIA	EQ 0.106MG BASE/INH	POWDER / INHALATION	RLD, RS	2025-05-23	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 116 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	N213005-001	10898494	2037-05-05	U-4200		2025-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-001	11660304	2037-05-05	U-4200		2025-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-001	11712442	2037-05-05	U-4200		2025-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-001	11744835	2037-05-05		Drug product	2025-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-001	11744836	2037-05-05		Drug product	2025-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-001	12390475	2037-05-05		Drug product	2025-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-002	10898494	2037-05-05	U-4200		2025-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-002	11660304	2037-05-05	U-4200		2025-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-002	11712442	2037-05-05	U-4200		2025-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-002	11744835	2037-05-05		Drug product	2025-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-002	11744836	2037-05-05		Drug product	2025-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-002	12390475	2037-05-05		Drug product	2025-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-003	10898494	2037-05-05	U-4200		2025-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-003	11660304	2037-05-05	U-4200		2025-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-003	11712442	2037-05-05	U-4200		2025-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-003	11744835	2037-05-05		Drug product	2025-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-003	11744836	2037-05-05		Drug product	2025-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-003	12390475	2037-05-05		Drug product	2025-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-004	10898494	2037-05-05	U-4200		2025-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-004	11660304	2037-05-05	U-4200		2025-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-004	11712442	2037-05-05	U-4200		2025-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-004	11744835	2037-05-05		Drug product	2025-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-004	11744836	2037-05-05		Drug product	2025-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-004	12390475	2037-05-05		Drug product	2025-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213005-001	10898494	2037-05-05	U-4200		2025-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-001	11660304	2037-05-05	U-4200		2025-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-001	11712442	2037-05-05	U-4200		2025-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-001	11744835	2037-05-05		Drug product	2025-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-001	11744836	2037-05-05		Drug product	2025-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-001	12390475	2037-05-05		Drug product	2025-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-002	10898494	2037-05-05	U-4200		2025-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-002	11660304	2037-05-05	U-4200		2025-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-002	11712442	2037-05-05	U-4200		2025-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-002	11744835	2037-05-05		Drug product	2025-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-002	11744836	2037-05-05		Drug product	2025-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-002	12390475	2037-05-05		Drug product	2025-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-003	10898494	2037-05-05	U-4200		2025-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-003	11660304	2037-05-05	U-4200		2025-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-003	11712442	2037-05-05	U-4200		2025-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-003	11744835	2037-05-05		Drug product	2025-06-13	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N213005-001	NP	2028-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-002	NP	2028-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-003	NP	2028-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213005-004	NP	2028-05-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213005-001	NP	2028-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-002	NP	2028-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-003	NP	2028-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213005-004	NP	2028-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213005-001	NP	2028-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213005-002	NP	2028-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213005-003	NP	2028-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213005-004	NP	2028-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213005-001	NP	2028-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213005-002	NP	2028-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213005-003	NP	2028-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213005-004	NP	2028-05-23	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213005-001	NP	2028-05-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213005-002	NP	2028-05-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213005-003	NP	2028-05-23	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213005-004	NP	2028-05-23	`a50c72e98297…`

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
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