Application 021272

Type: NDA
Sponsor: UNITED THERAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REMODULIN	TREPROSTINIL	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	1MG/ML	Yes	Yes
002	REMODULIN	TREPROSTINIL	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	2.5MG/ML	Yes	Yes
003	REMODULIN	TREPROSTINIL	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	5MG/ML	Yes	Yes
004	REMODULIN	TREPROSTINIL	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	10MG/ML	Yes	Yes
005	REMODULIN	TREPROSTINIL	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	20MG/ML	Yes	No
006	REMODULIN	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	0.1MG/ML	Yes	No
007	REMODULIN	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	0.2MG/ML	Yes	No
008	REMODULIN	TREPROSTINIL	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	0.4MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021272-001	REMODULIN	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21
N021272-002	REMODULIN	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21
N021272-003	REMODULIN	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21
N021272-004	REMODULIN	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21
N021272-005	REMODULIN	TREPROSTINIL	20MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2021-07-30
N021272-006	REMODULIN	TREPROSTINIL	0.1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2023-09-28
N021272-007	REMODULIN	TREPROSTINIL	0.2MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2023-09-28
N021272-008	REMODULIN	TREPROSTINIL	0.4MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2023-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021272-001	AP
N021272-002	AP
N021272-003	AP
N021272-004	AP

Orange Book patents#

Current patent rows page 1 of 1 · 40 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021272-001	8653137	2028-09-05	U-1437		2014-02-18
N021272-001	8658694	2028-09-05	U-1437		2014-02-25
N021272-001	11723887	2028-12-15		Drug substance	2023-08-15
N021272-001	9593066	2028-12-15		Drug substance	2017-03-14
N021272-001	7999007	2029-03-29	U-1437	Drug product	2011-08-23
N021272-002	8653137	2028-09-05	U-1437		2014-02-18
N021272-002	8658694	2028-09-05	U-1437		2014-02-25
N021272-002	11723887	2028-12-15		Drug substance	2023-08-15
N021272-002	9593066	2028-12-15		Drug substance	2017-03-14
N021272-002	7999007	2029-03-29	U-1437	Drug product
N021272-003	8653137	2028-09-05	U-1437		2014-02-18
N021272-003	8658694	2028-09-05	U-1437		2014-02-25
N021272-003	11723887	2028-12-15		Drug substance	2023-08-15
N021272-003	9593066	2028-12-15		Drug substance	2017-03-14
N021272-003	7999007	2029-03-29	U-1437	Drug product
N021272-004	8653137	2028-09-05	U-1437		2014-02-18
N021272-004	8658694	2028-09-05	U-1437		2014-02-25
N021272-004	11723887	2028-12-15		Drug substance	2023-08-15
N021272-004	9593066	2028-12-15		Drug substance	2017-03-14
N021272-004	7999007	2029-03-29	U-1437	Drug product
N021272-005	8653137	2028-09-05	U-1437		2021-08-24
N021272-005	8658694	2028-09-05	U-1437		2021-08-24
N021272-005	11723887	2028-12-15		Drug substance	2023-08-15
N021272-005	9593066	2028-12-15		Drug substance	2021-08-24
N021272-005	7999007	2029-03-29	U-1437	Drug product	2021-08-24
N021272-006	8653137	2028-09-05	U-1437		2023-10-20
N021272-006	8658694	2028-09-05	U-1437		2023-10-20
N021272-006	11723887	2028-12-15		Drug substance	2023-10-20
N021272-006	9593066	2028-12-15		Drug substance	2023-10-20
N021272-006	7999007	2029-03-29	U-1437	Drug product	2023-10-20
N021272-007	8653137	2028-09-05	U-1437		2023-10-20
N021272-007	8658694	2028-09-05	U-1437		2023-10-20
N021272-007	11723887	2028-12-15		Drug substance	2023-10-20
N021272-007	9593066	2028-12-15		Drug substance	2023-10-20
N021272-007	7999007	2029-03-29	U-1437	Drug product	2023-10-20
N021272-008	8653137	2028-09-05	U-1437		2023-10-20
N021272-008	8658694	2028-09-05	U-1437		2023-10-20
N021272-008	11723887	2028-12-15		Drug substance	2023-10-20
N021272-008	9593066	2028-12-15		Drug substance	2023-10-20
N021272-008	7999007	2029-03-29	U-1437	Drug product	2023-10-20

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 7 · 262 observed 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
2026-08-18 06:07:40	2026-07	N021272-001	REMODULIN	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-002	REMODULIN	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-003	REMODULIN	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-004	REMODULIN	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-005	REMODULIN	20MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2021-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-006	REMODULIN	0.1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2023-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-007	REMODULIN	0.2MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2023-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-008	REMODULIN	0.4MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2023-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021272-001	REMODULIN	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021272-002	REMODULIN	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021272-003	REMODULIN	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021272-004	REMODULIN	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021272-005	REMODULIN	20MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2021-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021272-006	REMODULIN	0.1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2023-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021272-007	REMODULIN	0.2MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2023-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021272-008	REMODULIN	0.4MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2023-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-001	REMODULIN	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-002	REMODULIN	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-003	REMODULIN	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-004	REMODULIN	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-005	REMODULIN	20MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2021-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-006	REMODULIN	0.1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2023-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-007	REMODULIN	0.2MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2023-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-008	REMODULIN	0.4MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2023-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021272-001	REMODULIN	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021272-002	REMODULIN	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021272-003	REMODULIN	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021272-004	REMODULIN	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021272-005	REMODULIN	20MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2021-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021272-006	REMODULIN	0.1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2023-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021272-007	REMODULIN	0.2MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD	2023-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021272-008	REMODULIN	0.4MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2023-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-001	REMODULIN	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-002	REMODULIN	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-003	REMODULIN	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-004	REMODULIN	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2002-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-005	REMODULIN	20MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2021-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-006	REMODULIN	0.1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2023-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-007	REMODULIN	0.2MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2023-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-008	REMODULIN	0.4MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2023-09-28	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021272-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021272-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021272-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021272-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021272-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021272-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021272-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021272-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021272-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021272-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021272-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021272-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021272-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021272-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021272-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021272-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021272-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021272-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021272-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021272-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021272-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021272-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021272-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021272-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021272-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021272-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021272-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021272-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021272-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021272-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021272-004	AP	1	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 53 · 2,086 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	N021272-001	8653137	2028-09-05	U-1437		2014-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-001	8658694	2028-09-05	U-1437		2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-001	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-001	9593066	2028-12-15		Drug substance	2017-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-001	7999007	2029-03-29	U-1437	Drug product	2011-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-002	8653137	2028-09-05	U-1437		2014-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-002	8658694	2028-09-05	U-1437		2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-002	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-002	9593066	2028-12-15		Drug substance	2017-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-002	7999007	2029-03-29	U-1437	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-003	8653137	2028-09-05	U-1437		2014-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-003	8658694	2028-09-05	U-1437		2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-003	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-003	9593066	2028-12-15		Drug substance	2017-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-003	7999007	2029-03-29	U-1437	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-004	8653137	2028-09-05	U-1437		2014-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-004	8658694	2028-09-05	U-1437		2014-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-004	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-004	9593066	2028-12-15		Drug substance	2017-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-004	7999007	2029-03-29	U-1437	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-005	8653137	2028-09-05	U-1437		2021-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-005	8658694	2028-09-05	U-1437		2021-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-005	11723887	2028-12-15		Drug substance	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-005	9593066	2028-12-15		Drug substance	2021-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-005	7999007	2029-03-29	U-1437	Drug product	2021-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-006	8653137	2028-09-05	U-1437		2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-006	8658694	2028-09-05	U-1437		2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-006	11723887	2028-12-15		Drug substance	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-006	9593066	2028-12-15		Drug substance	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-006	7999007	2029-03-29	U-1437	Drug product	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-007	8653137	2028-09-05	U-1437		2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-007	8658694	2028-09-05	U-1437		2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-007	11723887	2028-12-15		Drug substance	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-007	9593066	2028-12-15		Drug substance	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-007	7999007	2029-03-29	U-1437	Drug product	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-008	8653137	2028-09-05	U-1437		2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-008	8658694	2028-09-05	U-1437		2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-008	11723887	2028-12-15		Drug substance	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-008	9593066	2028-12-15		Drug substance	2023-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021272-008	7999007	2029-03-29	U-1437	Drug product	2023-10-20	`caaa826d4ba7…`

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
Remodulin	TREPROSTINIL	United Therapeutics Corporation	6c80bb38-e8db-4138-9f0d-dbbf9c673185	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021272 application number: NDA021272 ndc (product): 66302-110 ndc (product): 66302-102 ndc (product): 66302-120 ndc (product): 66302-150 ndc (product): 66302-101 ndc (product): 66302-105

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66302-101	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-101	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-101	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-101	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-101	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-102	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-102	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-102	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-102	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-102	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-105	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-105	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-105	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-105	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-105	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-110	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-110	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-110	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-110	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-110	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-120	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-120	Remodulin	treprostinil	United Therapeutics Corporation	NDA	Current
66302-150	Sterile Diluent for Remodulin	water	United Therapeutics Corporation	NDA	Current
66302-150	Sterile Diluent for Remodulin	water	United Therapeutics Corporation	NDA	Current
66302-150	Sterile Diluent for Remodulin	water	United Therapeutics Corporation	NDA	Current
66302-150	Sterile Diluent for Remodulin	water	United Therapeutics Corporation	NDA	Current
66302-150	Sterile Diluent for Remodulin	water	United Therapeutics Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74053	SUPPL	2023-04-25
73711	SUPPL	2023-03-08
68588	SUPPL	2021-09-13
68585	SUPPL	2021-09-13
66841	SUPPL	2021-03-23
66253	SUPPL	2021-02-17
55082	SUPPL	2018-08-03
55068	SUPPL	2018-07-31
54561	SUPPL	2018-06-14
54538	SUPPL	2018-06-12
45363	SUPPL	2016-09-27
21564	SUPPL	2015-11-18
27309	SUPPL	2014-12-30
42068	SUPPL	2014-01-16
4857	SUPPL	2013-10-01
36531	SUPPL	2013-09-27
14825	SUPPL	2013-09-27
27310	SUPPL	2013-09-26
21563	SUPPL	2011-10-10
27308	SUPPL	2011-02-14
36530	SUPPL	2011-02-09
4856	SUPPL	2010-01-15
36529	SUPPL	2010-01-12
14823	SUPPL	2008-09-19
27307	SUPPL	2008-09-16
14824	SUPPL	2008-02-14
4855	SUPPL	2008-02-07
27306	SUPPL	2006-03-23
14822	SUPPL	2006-03-22
27305	SUPPL	2006-01-30
21562	ORIG	2002-07-31
27304	ORIG	2002-05-21
14821	ORIG	2002-05-21