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Orange Book product · Brand (NDA)

DUONEB

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Brand (NDA)NDA 020950DISCN PHARMOBEDIENT
View ALBUTEROL SULFATE; IPRATROPIUM BROMIDE familyOpen on FDA Orange Book

At a glance

Mar 21, 2001

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 21, 2001

    25 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Strength

EQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 020950

Product number

001

Marketing status

DISCN

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.

Agent CTA Background

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