Application 209382

Type: ANDA
Sponsor: PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TREPROSTINIL	TREPROSTINIL	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	1MG/ML	No	No
002	TREPROSTINIL	TREPROSTINIL	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	2.5MG/ML	No	No
003	TREPROSTINIL	TREPROSTINIL	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	5MG/ML	No	No
004	TREPROSTINIL	TREPROSTINIL	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	10MG/ML	No	No

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	Approval date
A209382-001	TREPROSTINIL	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	2019-09-24
A209382-002	TREPROSTINIL	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	2019-09-24
A209382-003	TREPROSTINIL	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	2019-09-24
A209382-004	TREPROSTINIL	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	2019-09-24

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 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209382-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		2019-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209382-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		2019-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209382-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		2019-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209382-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		2019-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209382-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		2019-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209382-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		2019-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209382-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		2019-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209382-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		2019-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209382-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		2019-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209382-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		2019-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209382-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		2019-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209382-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS		2019-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209382-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209382-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209382-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209382-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209382-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209382-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209382-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209382-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209382-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209382-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209382-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209382-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209382-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209382-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209382-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209382-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209382-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209382-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209382-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209382-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209382-001	TREPROSTINIL	1MG/ML	INJECTABLE / IV (INFUSION), SUBCUTANEOUS	AP	2019-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209382-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / IV (INFUSION), SUBCUTANEOUS	AP	2019-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209382-003	TREPROSTINIL	5MG/ML	INJECTABLE / IV (INFUSION), SUBCUTANEOUS	AP	2019-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209382-004	TREPROSTINIL	10MG/ML	INJECTABLE / IV (INFUSION), SUBCUTANEOUS	AP	2019-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209382-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209382-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209382-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209382-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-24	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A209382-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209382-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209382-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209382-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209382-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209382-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209382-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209382-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209382-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209382-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209382-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209382-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209382-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209382-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209382-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209382-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209382-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209382-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209382-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209382-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209382-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209382-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209382-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209382-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209382-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209382-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209382-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209382-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209382-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209382-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209382-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209382-004	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209382-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209382-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209382-003	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209382-004	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209382-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209382-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209382-003	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209382-004	AP	1	`301d65b070ca…`

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 · 9 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	Name fallback generic name: TREPROSTINIL
TYVASO	TREPROSTINIL	United Therapeutics Corporation	cbc31ab1-a80f-4b50-a3b1-39910b0fb609	2026-04-14	Warnings, Adverse reactions	Name fallback generic name: TREPROSTINIL
Tyvaso DPI	TREPROSTINIL	United Therapeutics Corporation	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	2025-11-20	Warnings, Adverse reactions	Name fallback generic name: TREPROSTINIL
Yutrepia	TREPROSTINIL	Liquidia Technologies, Inc.	e8f6d534-115c-440e-bdbb-b443a29bb468	2025-09-08	Warnings, Adverse reactions	Name fallback generic name: TREPROSTINIL
Treprostinil	TREPROSTINIL	Alembic Pharmaceuticals Inc.	4a684b13-669d-4721-8ed4-30cc7762b0b8	2025-02-13	Warnings, Adverse reactions	Name fallback brand name: Treprostinil generic name: TREPROSTINIL
Orenitram	TREPROSTINIL	United Therapeutics Corporation	8ed2003a-c801-411e-831e-d06079bb0d7c	2024-11-20	Warnings, Adverse reactions	Name fallback generic name: TREPROSTINIL
Treprostinil	TREPROSTINIL	Sandoz Inc	473297ca-a872-4052-a053-87dc8f0d3c13	2023-04-06	Warnings, Adverse reactions	Name fallback brand name: Treprostinil generic name: TREPROSTINIL
Treprostinil	TREPROSTINIL	Teva Parenteral Medicines, Inc.	4b2ce4aa-4302-49db-9456-c8cf0e034968	2022-05-01	Warnings, Adverse reactions	Name fallback brand name: Treprostinil generic name: TREPROSTINIL
Sterile Diluent for Treprostinil	WATER	Dr.Reddy's Laboratories Inc.,	33050ee2-519b-1f0b-d4df-9e14dd329c57	2021-12-23	Warnings, Adverse reactions	Name fallback brand name: Treprostinil generic name: TREPROSTINIL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42023-206	Treprostinil	Treprostinil	Par Pharmaceutical, Inc.	ANDA	Current
42023-206	Treprostinil	Treprostinil	Par Pharmaceutical, Inc.	ANDA	Current
42023-207	Treprostinil	Treprostinil	Par Pharmaceutical, Inc.	ANDA	Current
42023-207	Treprostinil	Treprostinil	Par Pharmaceutical, Inc.	ANDA	Current
42023-208	Treprostinil	Treprostinil	Par Pharmaceutical, Inc.	ANDA	Current
42023-208	Treprostinil	Treprostinil	Par Pharmaceutical, Inc.	ANDA	Current
42023-209	Treprostinil	Treprostinil	Par Pharmaceutical, Inc.	ANDA	Current
42023-209	Treprostinil	Treprostinil	Par Pharmaceutical, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57321	ORIG	2019-01-22