Assyro AI

Orange Book product · Brand (NDA)

ULTIVA

REMIFENTANIL HYDROCHLORIDE

Brand (NDA)NDA 020630TE APRX MYLAN INSTITUTIONAL
View REMIFENTANIL HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Jul 12, 1996

Approved

Brand (NDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 12, 1996

    30 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

REMIFENTANIL HYDROCHLORIDE

Strength

EQ 2MG BASE/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

NDA 020630

Product number

002

Marketing status

RX

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.

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