Assyro AI

Orange Book product · Brand (NDA)

AGGRASTAT

TIROFIBAN HYDROCHLORIDE

Brand (NDA)NDA 020913TE APRX MEDICURE
View TIROFIBAN HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

May 17, 2002

Approved

Brand (NDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 17, 2002

    24 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TIROFIBAN HYDROCHLORIDE

Strength

EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

AP

Application

NDA 020913

Product number

002

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

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