Details for New Drug Application (NDA): 020913
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NDA 020913 describes AGGRASTAT, which is a drug marketed by Medicure and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the AGGRASTAT profile page.
The generic ingredient in AGGRASTAT is tirofiban hydrochloride. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tirofiban hydrochloride profile page.
The generic ingredient in AGGRASTAT is tirofiban hydrochloride. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the tirofiban hydrochloride profile page.
Summary for 020913
| Tradename: | AGGRASTAT |
| Applicant: | Medicure |
| Ingredient: | tirofiban hydrochloride |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020913
| Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 020913
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913 | NDA | Medicure International Inc | 25208-002 | 25208-002-01 | 1 BAG in 1 CARTON (25208-002-01) / 100 mL in 1 BAG |
| AGGRASTAT | tirofiban hydrochloride | SOLUTION;INTRAVENOUS | 020913 | NDA | Medicure International Inc | 25208-002 | 25208-002-02 | 1 CONTAINER in 1 CARTON (25208-002-02) / 250 mL in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) | ||||
| Approval Date: | May 14, 1998 | TE: | RLD: | No | |||||
| Patent: | See Plans and Pricing | Patent Expiration: | May 1, 2023 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A DOSING REGIMEN OF AGGRASTAT (TIROFIBAN HYDROCHLORIDE)(25MCG/KG FOLLOWED BY 0.15MCG/KG/MIN INFUSION) TO REDUCE THE RATE OF THROMBOTIC CORONARY EVENTS ASSOCIATED WITH ACUTE CORONARY SYNDROME (ACS) IN PATIENTS WITH NON-ST ELEVATION ACS | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) | ||||
| Approval Date: | May 17, 2002 | TE: | RLD: | Yes | |||||
| Patent: | See Plans and Pricing | Patent Expiration: | May 1, 2023 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A DOSING REGIMEN OF AGGRASTAT (TIROFIBAN HYDROCHLORIDE)(25MCG/KG FOLLOWED BY 0.15MCG/KG/MIN INFUSION) TO REDUCE THE RATE OF THROMBOTIC CORONARY EVENTS ASSOCIATED WITH ACUTE CORONARY SYNDROME (ACS) IN PATIENTS WITH NON-ST ELEVATION ACS | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) | ||||
| Approval Date: | Apr 20, 2000 | TE: | AP | RLD: | Yes | ||||
| Patent: | See Plans and Pricing | Patent Expiration: | May 1, 2023 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A DOSING REGIMEN OF AGGRASTAT (TIROFIBAN HYDROCHLORIDE)(25MCG/KG FOLLOWED BY 0.15MCG/KG/MIN INFUSION) TO REDUCE THE RATE OF THROMBOTIC CORONARY EVENTS ASSOCIATED WITH ACUTE CORONARY SYNDROME (ACS) IN PATIENTS WITH NON-ST ELEVATION ACS | ||||||||
Expired US Patents for NDA 020913
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