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Orange Book product · Generic (ANDA)

LEVALBUTEROL HYDROCHLORIDE

LEVALBUTEROL HYDROCHLORIDE

Generic (ANDA)ANDA 215217TE ANRX NEPHRON
View LEVALBUTEROL HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

May 26, 2026

Approved

Generic (ANDA)

Application

AN

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 26, 2026

    24 d ago

  2. Today

Pharmaceutical detail

Active ingredient

LEVALBUTEROL HYDROCHLORIDE

Strength

EQ 0.021% BASE

Dosage form

SOLUTION

Route

INHALATION

TE code

AN

Application

ANDA 215217

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of LEVALBUTEROL 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

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