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Orange Book product · Generic (ANDA)

TIROFIBAN HYDROCHLORIDE

TIROFIBAN HYDROCHLORIDE

Generic (ANDA)ANDA 206888TE APRX GLAND

At a glance

Apr 08, 2021

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 08, 2021

    5 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TIROFIBAN HYDROCHLORIDE

Strength

EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

AP

Application

ANDA 206888

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of TIROFIBAN HYDROCHLORIDE

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.