Application 206648

Type: ANDA
Sponsor: TEVA PHARMS USA

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	TE codes	Approval date
A206648-001	TREPROSTINIL	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26
A206648-002	TREPROSTINIL	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26
A206648-003	TREPROSTINIL	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26
A206648-004	TREPROSTINIL	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206648-001	AP
A206648-002	AP
A206648-003	AP
A206648-004	AP

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	A206648-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206648-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206648-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206648-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206648-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206648-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206648-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206648-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206648-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206648-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206648-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206648-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206648-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206648-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206648-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206648-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206648-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206648-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206648-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206648-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206648-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206648-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206648-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206648-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206648-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206648-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206648-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206648-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206648-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206648-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206648-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206648-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206648-001	TREPROSTINIL	1MG/ML	INJECTABLE / IV (INFUSION), SUBCUTANEOUS	AP	2019-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206648-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / IV (INFUSION), SUBCUTANEOUS	AP	2019-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206648-003	TREPROSTINIL	5MG/ML	INJECTABLE / IV (INFUSION), SUBCUTANEOUS	AP	2019-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206648-004	TREPROSTINIL	10MG/ML	INJECTABLE / IV (INFUSION), SUBCUTANEOUS	AP	2019-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206648-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206648-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206648-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206648-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2019-09-26	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 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	A206648-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206648-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206648-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206648-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206648-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206648-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206648-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206648-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206648-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206648-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206648-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206648-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206648-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206648-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206648-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206648-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206648-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206648-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206648-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206648-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206648-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206648-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206648-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206648-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206648-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206648-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206648-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206648-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206648-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206648-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206648-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206648-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206648-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206648-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206648-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206648-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206648-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206648-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206648-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206648-004	AP	1	`d8e5a09893c0…`

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
Treprostinil	TREPROSTINIL	Teva Parenteral Medicines, Inc.	4b2ce4aa-4302-49db-9456-c8cf0e034968	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206648 application number: ANDA206648 ndc (product): 0703-0686 ndc (product): 0703-0696 ndc (product): 0703-0676 ndc (product): 0703-0666

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
0703-0666	Treprostinil	Treprostinil	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-0666	Treprostinil	Treprostinil	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-0666	Treprostinil	Treprostinil	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-0676	Treprostinil	Treprostinil	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-0676	Treprostinil	Treprostinil	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-0676	Treprostinil	Treprostinil	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-0686	Treprostinil	Treprostinil	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-0686	Treprostinil	Treprostinil	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-0686	Treprostinil	Treprostinil	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-0696	Treprostinil	Treprostinil	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-0696	Treprostinil	Treprostinil	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-0696	Treprostinil	Treprostinil	Teva Parenteral Medicines, Inc.	ANDA	Current