Orange Book product · Brand (NDA)

XOPENEX

LEVALBUTEROL HYDROCHLORIDE

Brand (NDA)NDA 020837DISCN HIKMA

View LEVALBUTEROL HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Jan 30, 2002

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Jan 30, 2002
24 yr 9 mo ago
Today

Pharmaceutical detail

Active ingredient

LEVALBUTEROL HYDROCHLORIDE

Strength

EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

SOLUTION

Route

INHALATION

TE code

Not listed

Application

NDA 020837

Product number

003

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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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