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Orange Book product · Generic (ANDA)

ALBUTEROL SULFATE

ALBUTEROL SULFATE

Generic (ANDA)ANDA 210948TE BXRX AIZANT

At a glance

Mar 15, 2019

Approved

Generic (ANDA)

Application

BX

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 15, 2019

    7 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ALBUTEROL SULFATE

Strength

EQ 2MG BASE

Dosage form

TABLET

Route

ORAL

TE code

BX

Application

ANDA 210948

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.