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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 are six patents protecting this drug. Additional details are available on the AGGRASTAT profile page.

The generic ingredient in AGGRASTAT is tirofiban hydrochloride. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tirofiban hydrochloride profile page.

Summary for NDA: 020912

Tradename:
AGGRASTAT
Applicant:
Medicure
Ingredient:
tirofiban hydrochloride
Patents:6
Formulation / Manufacturing:see details

Pharmacology for NDA: 020912

Physiological EffectDecreased 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

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)
Approval Date:May 14, 1998TE:RLD:No
Patent:5,733,919Patent Expiration:Oct 23, 2016Product Flag?Substance Flag?Delist Request?
Patent:5,965,581Patent Expiration:Oct 23, 2016Product Flag?Substance Flag?Delist Request?
Patent:5,972,967Patent Expiration:Oct 23, 2016Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 020912

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medicure
AGGRASTAT
tirofiban hydrochloride
SOLUTION;INJECTION020912-002Aug 31, 20165,965,581► subscribe
Medicure
AGGRASTAT
tirofiban hydrochloride
INJECTABLE;INJECTION020912-001May 14, 19985,292,756► subscribe
Medicure
AGGRASTAT
tirofiban hydrochloride
SOLUTION;INJECTION020912-002Aug 31, 20165,733,919► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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