Assyro AI

Orange Book product · Generic (ANDA)

EPTIFIBATIDE

EPTIFIBATIDE

Generic (ANDA)ANDA 203258TE APRX MYLAN LABS LTD

At a glance

Jul 20, 2018

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 20, 2018

    8 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

EPTIFIBATIDE

Strength

2MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 203258

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of EPTIFIBATIDE

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.