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 42.

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.

Product history page 1 of 4 · 130 observed 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	N214324-001	TYVASO DPI	0.016MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-002	TYVASO DPI	0.032MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-003	TYVASO DPI	0.048MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-004	TYVASO DPI	0.064MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-005	TYVASO DPI	0.08MG/INH	POWDER / INHALATION	RLD, RS	2024-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214324-001	TYVASO DPI	0.016MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-002	TYVASO DPI	0.032MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-003	TYVASO DPI	0.048MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-004	TYVASO DPI	0.064MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-005	TYVASO DPI	0.08MG/INH	POWDER / INHALATION	RLD, RS	2024-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214324-001	TYVASO DPI	0.016MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214324-002	TYVASO DPI	0.032MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214324-003	TYVASO DPI	0.048MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214324-004	TYVASO DPI	0.064MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214324-005	TYVASO DPI	0.08MG/INH	POWDER / INHALATION	RLD, RS	2024-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214324-001	TYVASO DPI	0.016MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214324-002	TYVASO DPI	0.032MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214324-003	TYVASO DPI	0.048MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214324-004	TYVASO DPI	0.064MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214324-005	TYVASO DPI	0.08MG/INH	POWDER / INHALATION	RLD, RS	2024-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214324-001	TYVASO DPI	0.016MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214324-002	TYVASO DPI	0.032MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214324-003	TYVASO DPI	0.048MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214324-004	TYVASO DPI	0.064MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214324-005	TYVASO DPI	0.08MG/INH	POWDER / INHALATION	RLD, RS	2024-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214324-001	TYVASO DPI	0.016MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214324-002	TYVASO DPI	0.032MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214324-003	TYVASO DPI	0.048MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214324-004	TYVASO DPI	0.064MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214324-005	TYVASO DPI	0.08MG/INH	POWDER / INHALATION	RLD, RS	2024-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214324-001	TYVASO DPI	0.016MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214324-002	TYVASO DPI	0.032MG/INH	POWDER / INHALATION	RLD	2022-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214324-003	TYVASO DPI	0.048MG/INH	POWDER / INHALATION	RLD	2022-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214324-004	TYVASO DPI	0.064MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214324-005	TYVASO DPI	0.08MG/INH	POWDER / INHALATION	RLD	2024-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214324-001	TYVASO DPI	0.016MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214324-002	TYVASO DPI	0.032MG/INH	POWDER / INHALATION	RLD	2022-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214324-003	TYVASO DPI	0.048MG/INH	POWDER / INHALATION	RLD	2022-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214324-004	TYVASO DPI	0.064MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214324-005	TYVASO DPI	0.08MG/INH	POWDER / INHALATION	RLD	2024-10-24	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 22 · 864 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	N214324-001	11357782	2027-05-14	U-1849		2025-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-001	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-001	9593066	2028-12-15		Drug substance	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-001	10772883	2030-06-11		Drug product	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-001	10421729	2035-04-01		Drug product	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-001	11826327	2042-02-03	U-3749		2023-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-002	11357782	2027-05-14	U-1849		2025-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-002	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-002	9593066	2028-12-15		Drug substance	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-002	10772883	2030-06-11		Drug product	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-002	10421729	2035-04-01		Drug product	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-002	11826327	2042-02-03	U-3749		2023-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-003	11357782	2027-05-14	U-1849		2025-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-003	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-003	9593066	2028-12-15		Drug substance	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-003	10772883	2030-06-11		Drug product	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-003	10421729	2035-04-01		Drug product	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-003	11826327	2042-02-03	U-3749		2023-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-004	11357782	2027-05-14	U-1849		2025-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-004	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-004	9593066	2028-12-15		Drug substance	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-004	10772883	2030-06-11		Drug product	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-004	10421729	2035-04-01		Drug product	2022-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-004	11826327	2042-02-03	U-3749		2023-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-005	11357782	2027-05-14	U-1849		2025-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-005	11723887	2028-12-15		Drug substance	2024-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-005	9593066	2028-12-15		Drug substance	2024-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-005	10772883	2030-06-11		Drug product	2024-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-005	10421729	2035-04-01		Drug product	2024-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214324-005	11826327	2042-02-03	U-3749		2024-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214324-001	11357782	2027-05-14	U-1849		2025-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-001	11723887	2028-12-15		Drug substance	2023-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-001	9593066	2028-12-15		Drug substance	2022-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-001	10772883	2030-06-11		Drug product	2022-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-001	10421729	2035-04-01		Drug product	2022-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-001	11826327	2042-02-03	U-3749		2023-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-002	11357782	2027-05-14	U-1849		2025-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-002	11723887	2028-12-15		Drug substance	2023-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-002	9593066	2028-12-15		Drug substance	2022-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214324-002	10772883	2030-06-11		Drug product	2022-06-17	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214324-001	NP	2025-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214324-002	NP	2025-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214324-003	NP	2025-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214324-004	NP	2025-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214324-001	NP	2025-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214324-002	NP	2025-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214324-003	NP	2025-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214324-004	NP	2025-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214324-001	NP	2025-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214324-002	NP	2025-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214324-003	NP	2025-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214324-004	NP	2025-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214324-001	NP	2025-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214324-002	NP	2025-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214324-003	NP	2025-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214324-004	NP	2025-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214324-001	NP	2025-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214324-002	NP	2025-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214324-003	NP	2025-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214324-004	NP	2025-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214324-001	NP	2025-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214324-002	NP	2025-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214324-003	NP	2025-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214324-004	NP	2025-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214324-001	NP	2025-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214324-002	NP	2025-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214324-003	NP	2025-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214324-004	NP	2025-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214324-001	NP	2025-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214324-002	NP	2025-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214324-003	NP	2025-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214324-004	NP	2025-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214324-001	NP	2025-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214324-002	NP	2025-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214324-003	NP	2025-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214324-004	NP	2025-05-23	`d06236e962d9…`

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
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