Application 020913

Type: NDA
Sponsor: MEDICURE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AGGRASTAT	TIROFIBAN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	No	No
002	AGGRASTAT	TIROFIBAN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	Yes	No
003	AGGRASTAT	TIROFIBAN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020913-001	AGGRASTAT	TIROFIBAN HYDROCHLORIDE	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14
N020913-002	AGGRASTAT	TIROFIBAN HYDROCHLORIDE	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17
N020913-003	AGGRASTAT	TIROFIBAN HYDROCHLORIDE	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020913-002	AP
N020913-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020913-002	AGGRASTAT	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD	2002-05-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020913-003	AGGRASTAT	EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2000-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020913-001	AGGRASTAT	EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)	SOLUTION / INTRAVENOUS			1998-05-14	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020913-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020913-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020913-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020913-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020913-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020913-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020913-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020913-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020913-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020913-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020913-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020913-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020913-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020913-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020913-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020913-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020913-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020913-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020913-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020913-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020913-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020913-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020913-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020913-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020913-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020913-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020913-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020913-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020913-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020913-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020913-003	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N020913-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020913-003	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020913-002	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020913-003	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020913-002	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020913-003	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020913-002	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020913-003	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020913-002	AP	1	`a72a2bbeb626…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020913-001	6770660	2023-05-01	U-1444		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020913-002	6770660	2023-05-01	U-1444		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020913-001	6770660	2023-05-01	U-1444		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020913-002	6770660	2023-05-01	U-1444		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020913-001	6770660	2023-05-01	U-1444		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020913-002	6770660	2023-05-01	U-1444		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020913-001	6136794	2019-01-29			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020913-001	6770660	2023-05-01	U-1444		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020913-002	6136794	2019-01-29			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020913-002	6770660	2023-05-01	U-1444		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020913-003	6136794	2019-01-29			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020913-001	6770660	2023-05-01	U-1444		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020913-002	6770660	2023-05-01	U-1444		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020913-001	6770660	2023-05-01	U-1444		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020913-002	6770660	2023-05-01	U-1444		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020913-001	6770660	2023-05-01	U-1444		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020913-002	6770660	2023-05-01	U-1444		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020913-001	6770660	2023-05-01	U-1444		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020913-002	6770660	2023-05-01	U-1444		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020913-001	6770660	2023-05-01	U-1444		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020913-002	6770660	2023-05-01	U-1444		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020913-001	6770660	2023-05-01	U-1444		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020913-002	6770660	2023-05-01	U-1444		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020913-001	6136794	2019-01-29			`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020913-001	6770660	2023-05-01	U-1444		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020913-002	6136794	2019-01-29			`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020913-002	6770660	2023-05-01	U-1444		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020913-003	6136794	2019-01-29			`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020913-003	6770660	2023-05-01	U-1444	2013-11-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020913-001	6136794	2019-01-29			`b00525d2431f…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AGGRASTAT	TIROFIBAN	Medicure International Inc	fe0ced75-ccbf-4d2e-bd0d-b57e60ab913f	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020913 application number: NDA020913 ndc (product): 25208-002
AGGRASTAT	TIROFIBAN	Medicure International Inc	e850111f-e713-41a2-9c65-21c517cf5511	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020913 application number: NDA020913

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25208-002	AGGRASTAT	TIROFIBAN	Medicure International Inc	NDA	Current
25208-002	AGGRASTAT	TIROFIBAN	Medicure International Inc	NDA	Current
25208-002	AGGRASTAT	TIROFIBAN	Medicure International Inc	NDA	Current
25208-002	AGGRASTAT	TIROFIBAN	Medicure International Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67915	SUPPL	2021-06-28
67880	SUPPL	2021-06-24
58794	SUPPL	2019-05-20
58769	SUPPL	2019-05-17
45213	SUPPL	2016-09-07
35637	SUPPL	2015-04-28
3739	SUPPL	2015-04-22
13731	SUPPL	2012-06-11
26186	SUPPL	2012-06-08
41807	ORIG	2010-06-04
41808	SUPPL	2004-05-26
21275	SUPPL	2004-05-26
3738	SUPPL	2003-07-24
26184	SUPPL	2002-07-24
26185	SUPPL	2002-05-17
3737	SUPPL	2001-09-25
3736	SUPPL	2001-03-23
35636	SUPPL	1999-07-09
26183	SUPPL	1999-07-09
35635	ORIG	1998-05-14
3735	ORIG	1998-05-14