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Orange Book product · Generic (ANDA)

ALBUTEROL SULFATE

ALBUTEROL SULFATE

Generic (ANDA)ANDA 209959TE AB1RX CIPLA

At a glance

Apr 08, 2020

Approved

Generic (ANDA)

Application

AB1

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 08, 2020

    6 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ALBUTEROL SULFATE

Strength

EQ 0.09MG BASE/INH

Dosage form

AEROSOL, METERED

Route

INHALATION

TE code

AB1

Application

ANDA 209959

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ALBUTEROL SULFATE

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.