Assyro AI

Orange Book product · Brand (NDA)

VENTAVIS

ILOPROST

Brand (NDA)NDA 021779DISCN ACTELION

At a glance

Dec 08, 2005

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 08, 2005

    20 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ILOPROST

Strength

10MCG/ML (10MCG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

SOLUTION

Route

INHALATION

TE code

Not listed

Application

NDA 021779

Product number

002

Marketing status

DISCN

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

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