Application 213947

Type: ANDA
Sponsor: NEXUS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIROFIBAN HYDROCHLORIDE	TIROFIBAN HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	No	No
002	TIROFIBAN HYDROCHLORIDE	TIROFIBAN HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213947-001	TIROFIBAN HYDROCHLORIDE	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2023-02-07
A213947-002	TIROFIBAN HYDROCHLORIDE	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP		2023-07-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A213947-001	AP
A213947-002	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 2 · 45 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	A213947-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213947-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213947-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213947-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213947-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213947-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213947-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213947-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213947-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213947-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213947-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213947-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213947-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213947-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213947-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213947-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213947-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213947-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213947-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213947-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213947-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213947-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213947-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213947-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213947-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-02-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213947-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213947-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-02-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213947-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213947-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-02-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213947-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-07-24	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213947-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-02-07	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213947-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-07-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213947-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-02-07	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213947-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-07-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213947-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-02-07	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213947-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-07-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213947-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-02-07	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213947-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-07-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213947-001	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-02-07	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213947-002	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	2023-07-24	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 45 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	A213947-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213947-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213947-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213947-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213947-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213947-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213947-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213947-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213947-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213947-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213947-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213947-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213947-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213947-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213947-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213947-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213947-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213947-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213947-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213947-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213947-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213947-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213947-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213947-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213947-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213947-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213947-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213947-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213947-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213947-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213947-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213947-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213947-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213947-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213947-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213947-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213947-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213947-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213947-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213947-002	AP	1	`9b2671bbb829…`

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
Tirofiban Hydrochloride	TIROFIBAN HYDROCHLORIDE	Nexus Pharmaceuticals LLC	7731e46a-2121-441b-b090-12dcefe240f0	2025-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213947 application number: ANDA213947

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73754	ORIG	2023-03-14