Assyro AI

Orange Book product · Brand (NDA)

IXEMPRA KIT

IXABEPILONE

Brand (NDA)NDA 022065RX R-PHARM US LLC

At a glance

Oct 16, 2007

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 16, 2007

    18 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

IXABEPILONE

Strength

15MG/VIAL

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 022065

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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.