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Orange Book product · Generic (ANDA)

LEVALBUTEROL HYDROCHLORIDE

LEVALBUTEROL HYDROCHLORIDE

Generic (ANDA)ANDA 218770DISCN MANKIND PHARMA
View LEVALBUTEROL HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Oct 21, 2024

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 21, 2024

    1 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LEVALBUTEROL HYDROCHLORIDE

Strength

EQ 0.0103% BASE

Dosage form

SOLUTION

Route

INHALATION

TE code

Not listed

Application

ANDA 218770

Product number

001

Marketing status

DISCN

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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