Assyro AI

Orange Book product · Brand (NDA)

ISTODAX

ROMIDEPSIN

Brand (NDA)NDA 022393TE APRX BRISTOL-MYERS
View ROMIDEPSIN familyOpen on FDA Orange Book

At a glance

Nov 05, 2009

Approved

Brand (NDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 05, 2009

    16 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ROMIDEPSIN

Strength

10MG/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

AP

Application

NDA 022393

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.

Book a Demo