Details for New Drug Application (NDA): 020912
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NDA 020912 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 020912
| Tradename: | AGGRASTAT |
| Applicant: | Medicure |
| Ingredient: | tirofiban hydrochloride |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020912
| Physiological Effect | Decreased Platelet Aggregation |
Suppliers and Packaging for NDA: 020912
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020912 | NDA | Medicure International Inc | 25208-001 | 25208-001-04 | 1 VIAL, GLASS in 1 CARTON (25208-001-04) / 15 mL in 1 VIAL, GLASS |
| AGGRASTAT | tirofiban hydrochloride | SOLUTION;INJECTION | 020912 | NDA | Medicure International Inc | 25208-001 | 25208-001-04 | 1 VIAL, GLASS in 1 CARTON (25208-001-04) / 15 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 12.5MG BASE/50ML (EQ 0.25MG 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;INJECTION | Strength | EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML) | ||||
| Approval Date: | Aug 31, 2016 | 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 | ||||||||
Expired US Patents for NDA 020912
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020912-001 | May 14, 1998 | See Plans and Pricing | See Plans and Pricing |
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020912-001 | May 14, 1998 | See Plans and Pricing | See Plans and Pricing |
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020912-001 | May 14, 1998 | See Plans and Pricing | See Plans and Pricing |
| Medicure | AGGRASTAT | tirofiban hydrochloride | INJECTABLE;INJECTION | 020912-001 | May 14, 1998 | See Plans and Pricing | See Plans and Pricing |
| Medicure | AGGRASTAT | tirofiban hydrochloride | SOLUTION;INJECTION | 020912-002 | Aug 31, 2016 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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