Assyro AI

Orange Book product · Brand (NDA)

ULTANE

SEVOFLURANE

Brand (NDA)NDA 020478TE ANRX ABBVIE

At a glance

Jun 07, 1995

Approved

Brand (NDA)

Application

AN

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 07, 1995

    31 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

SEVOFLURANE

Strength

100%

Dosage form

LIQUID

Route

INHALATION

TE code

AN

Application

NDA 020478

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.