Application 216897

Type: ANDA
Sponsor: ONESOURCE SPECIALTY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	INJECTABLE;INJECTION	EQ 0.25MG BASE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216897-001	CARBOPROST TROMETHAMINE	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP		2023-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216897-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216897-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216897-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216897-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216897-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216897-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216897-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216897-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216897-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216897-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216897-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216897-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216897-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216897-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-07-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216897-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-07-25	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216897-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-07-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216897-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-07-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216897-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-07-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216897-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-07-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216897-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-07-25	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216897-001	CARBOPROST TROMETHAMINE	EQ 0.25MG BASE/ML	INJECTABLE / INJECTION	AP	2023-07-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216897-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216897-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216897-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216897-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216897-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216897-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216897-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216897-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216897-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216897-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216897-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216897-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216897-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216897-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216897-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216897-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216897-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216897-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216897-001	AP	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216897-001	AP	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carboprost Tromethamine	CARBOPROST TROMETHAMINE	Hikma Pharmaceuticals USA Inc.	aa42587d-7213-4a46-9050-9bbfbb081de5	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216897 application number: ANDA216897
Carboprost Tromethamine	CARBOPROST TROMETHAMINE	ONESOURCE SPECIALTY PHARMA LIMITED	461f80d0-b66c-f093-e063-6294a90a8893	2025-08-29	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 216897 application number: ANDA216897
Carboprost Tromethamine	CARBOPROST TROMETHAMINE	Xellia Pharmaceuticals USA LLC	8a1284cf-002f-4887-a3c0-d73d04b2b869	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216897 application number: ANDA216897