Assyro AI

Orange Book product · Generic (ANDA)

EPOPROSTENOL SODIUM

EPOPROSTENOL SODIUM

Generic (ANDA)ANDA 078396RX MEITHEAL

At a glance

Apr 23, 2008

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 23, 2008

    18 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

EPOPROSTENOL SODIUM

Strength

EQ 0.5MG BASE/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 078396

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of EPOPROSTENOL SODIUM

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.