Application 214324

Type: NDA
Sponsor: UNITED THERAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TYVASO DPI	TREPROSTINIL	POWDER;INHALATION	16MCG	Yes	No
002	TYVASO DPI	TREPROSTINIL	POWDER;INHALATION	0.032MG/INH	Yes	Yes
003	TYVASO DPI	TREPROSTINIL	POWDER;INHALATION	0.048MG/INH	Yes	Yes
004	TYVASO DPI	TREPROSTINIL	POWDER;INHALATION	0.064MG/INH	Yes	Yes
005	TYVASO DPI	TREPROSTINIL	POWDER;INHALATION	0.08MG/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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N214324-001	TYVASO DPI	TREPROSTINIL	0.016MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23
N214324-002	TYVASO DPI	TREPROSTINIL	0.032MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23
N214324-003	TYVASO DPI	TREPROSTINIL	0.048MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23
N214324-004	TYVASO DPI	TREPROSTINIL	0.064MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23
N214324-005	TYVASO DPI	TREPROSTINIL	0.08MG/INH	POWDER / INHALATION	RLD, RS	2024-10-24

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214324-001	11357782	2027-05-14	U-1849		2025-04-24
N214324-001	11723887	2028-12-15		Drug substance	2023-08-15
N214324-001	9593066	2028-12-15		Drug substance	2022-06-17
N214324-001	10772883	2030-06-11		Drug product	2022-06-17
N214324-001	10421729	2035-04-01		Drug product	2022-06-17
N214324-001	11826327	2042-02-03	U-3749		2023-11-28
N214324-002	11357782	2027-05-14	U-1849		2025-04-24
N214324-002	11723887	2028-12-15		Drug substance	2023-08-15
N214324-002	9593066	2028-12-15		Drug substance	2022-06-17
N214324-002	10772883	2030-06-11		Drug product	2022-06-17
N214324-002	10421729	2035-04-01		Drug product	2022-06-17
N214324-002	11826327	2042-02-03	U-3749		2023-11-28
N214324-003	11357782	2027-05-14	U-1849		2025-04-24
N214324-003	11723887	2028-12-15		Drug substance	2023-08-15
N214324-003	9593066	2028-12-15		Drug substance	2022-06-17
N214324-003	10772883	2030-06-11		Drug product	2022-06-17
N214324-003	10421729	2035-04-01		Drug product	2022-06-17
N214324-003	11826327	2042-02-03	U-3749		2023-11-28
N214324-004	11357782	2027-05-14	U-1849		2025-04-24
N214324-004	11723887	2028-12-15		Drug substance	2023-08-15
N214324-004	9593066	2028-12-15		Drug substance	2022-06-17
N214324-004	10772883	2030-06-11		Drug product	2022-06-17
N214324-004	10421729	2035-04-01		Drug product	2022-06-17
N214324-004	11826327	2042-02-03	U-3749		2023-11-28
N214324-005	11357782	2027-05-14	U-1849		2025-04-24
N214324-005	11723887	2028-12-15		Drug substance	2024-11-18
N214324-005	9593066	2028-12-15		Drug substance	2024-11-18
N214324-005	10772883	2030-06-11		Drug product	2024-11-18
N214324-005	10421729	2035-04-01		Drug product	2024-11-18
N214324-005	11826327	2042-02-03	U-3749		2024-11-18

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
2026-08-01 22:54:32	2026-06	N214324-001	TYVASO DPI	0.016MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-002	TYVASO DPI	0.032MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-003	TYVASO DPI	0.048MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-004	TYVASO DPI	0.064MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-005	TYVASO DPI	0.08MG/INH	POWDER / INHALATION	RLD, RS	2024-10-24	`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	N214324-001	11357782	2027-05-14	U-1849		2025-04-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-001	11723887	2028-12-15		Drug substance	2023-08-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-001	9593066	2028-12-15		Drug substance	2022-06-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-001	10772883	2030-06-11		Drug product	2022-06-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-001	10421729	2035-04-01		Drug product	2022-06-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-001	11826327	2042-02-03	U-3749		2023-11-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-002	11357782	2027-05-14	U-1849		2025-04-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-002	11723887	2028-12-15		Drug substance	2023-08-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-002	9593066	2028-12-15		Drug substance	2022-06-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-002	10772883	2030-06-11		Drug product	2022-06-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-002	10421729	2035-04-01		Drug product	2022-06-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-002	11826327	2042-02-03	U-3749		2023-11-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-003	11357782	2027-05-14	U-1849		2025-04-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-003	11723887	2028-12-15		Drug substance	2023-08-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-003	9593066	2028-12-15		Drug substance	2022-06-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-003	10772883	2030-06-11		Drug product	2022-06-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-003	10421729	2035-04-01		Drug product	2022-06-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-003	11826327	2042-02-03	U-3749		2023-11-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-004	11357782	2027-05-14	U-1849		2025-04-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-004	11723887	2028-12-15		Drug substance	2023-08-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-004	9593066	2028-12-15		Drug substance	2022-06-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-004	10772883	2030-06-11		Drug product	2022-06-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-004	10421729	2035-04-01		Drug product	2022-06-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-004	11826327	2042-02-03	U-3749		2023-11-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-005	11357782	2027-05-14	U-1849		2025-04-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-005	11723887	2028-12-15		Drug substance	2024-11-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-005	9593066	2028-12-15		Drug substance	2024-11-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-005	10772883	2030-06-11		Drug product	2024-11-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-005	10421729	2035-04-01		Drug product	2024-11-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N214324-005	11826327	2042-02-03	U-3749		2024-11-18	`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
Tyvaso DPI	TREPROSTINIL	United Therapeutics Corporation	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214324 application number: NDA214324 ndc (product): 66302-764 ndc (product): 66302-648 ndc (product): 66302-616 ndc (product): 66302-732 ndc (product): 66302-716 ndc (product): 66302-748 ndc (product): 66302-620 ndc (product): 66302-632 ndc (product): 66302-600 ndc (product): 66302-664 ndc (product): 66302-610 ndc (product): 66302-720

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66302-600	Tyvaso DPI	treprostinil	United Therapeutics Corporation	NDA	Current
66302-610	Tyvaso DPI	treprostinil	United Therapeutics Corporation	NDA	Current
66302-616	Tyvaso DPI	treprostinil	United Therapeutics Corporation	NDA	Current
66302-620	Tyvaso DPI	treprostinil	United Therapeutics Corporation	NDA	Current
66302-632	Tyvaso DPI	treprostinil	United Therapeutics Corporation	NDA	Current
66302-648	Tyvaso DPI	treprostinil	United Therapeutics Corporation	NDA	Current
66302-664	Tyvaso DPI	treprostinil	United Therapeutics Corporation	NDA	Current
66302-716	Tyvaso DPI	treprostinil	United Therapeutics Corporation	NDA	Current
66302-720	Tyvaso DPI	treprostinil	United Therapeutics Corporation	NDA	Current
66302-732	Tyvaso DPI	treprostinil	United Therapeutics Corporation	NDA	Current
66302-748	Tyvaso DPI	treprostinil	United Therapeutics Corporation	NDA	Current
66302-764	Tyvaso DPI	treprostinil	United Therapeutics Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71519	ORIG	2022-07-06
71138	ORIG	2022-05-24
71137	ORIG	2022-05-24