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Orange Book product · Generic (ANDA)

REMIFENTANIL HYDROCHLORIDE

REMIFENTANIL HYDROCHLORIDE

Generic (ANDA)ANDA 215635TE APRX NIVAGEN PHARMS INC

At a glance

Jun 28, 2024

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 28, 2024

    2 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

REMIFENTANIL HYDROCHLORIDE

Strength

EQ 1MG BASE/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

AP

Application

ANDA 215635

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of REMIFENTANIL HYDROCHLORIDE

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.