Home Applications 020913 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 44 .
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.
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 2 of 4 · 132 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 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…2024-05-31 18:47 UTC 2024-05 N020913-002 AGGRASTAT EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD 2002-05-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020913-003 AGGRASTAT EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-04-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020913-001 AGGRASTAT EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS 1998-05-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020913-002 AGGRASTAT EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2002-05-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020913-003 AGGRASTAT EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-04-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020913-001 AGGRASTAT EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS 1998-05-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020913-002 AGGRASTAT EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2002-05-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020913-003 AGGRASTAT EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-04-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020913-001 AGGRASTAT EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS 1998-05-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020913-002 AGGRASTAT EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2002-05-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020913-003 AGGRASTAT EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-04-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020913-001 AGGRASTAT EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020913-002 AGGRASTAT EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) INJECTABLE / INJECTION RLD 2002-05-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020913-003 AGGRASTAT EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2000-04-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020913-001 AGGRASTAT EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS 1998-05-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020913-002 AGGRASTAT EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2002-05-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020913-003 AGGRASTAT EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-04-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020913-001 AGGRASTAT EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS 1998-05-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020913-002 AGGRASTAT EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2002-05-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020913-003 AGGRASTAT EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2000-04-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020913-001 AGGRASTAT EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020913-002 AGGRASTAT EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) INJECTABLE / INJECTION RLD 2002-05-17 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020913-003 AGGRASTAT EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2000-04-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020913-001 AGGRASTAT EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020913-002 AGGRASTAT EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) INJECTABLE / INJECTION RLD 2002-05-17 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020913-003 AGGRASTAT EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2000-04-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020913-001 AGGRASTAT EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020913-002 AGGRASTAT EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) INJECTABLE / INJECTION RLD 2002-05-17 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020913-003 AGGRASTAT EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) INJECTABLE / INJECTION RLD, RS 2000-04-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020913-001 AGGRASTAT EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) INJECTABLE / INJECTION 1998-05-14 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N020913-002 AGGRASTAT EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) INJECTABLE / INJECTION RLD 2002-05-17 c0c555d07b60…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 62 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 84 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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