Assyro AI

Orange Book product · Generic (ANDA)

ALBUTEROL SULFATE

ALBUTEROL SULFATE

Generic (ANDA)ANDA 215571TE ANRX LEXENPHARM

At a glance

May 03, 2024

Approved

Generic (ANDA)

Application

AN

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 03, 2024

    2 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ALBUTEROL SULFATE

Strength

EQ 0.021% BASE

Dosage form

SOLUTION

Route

INHALATION

TE code

AN

Application

ANDA 215571

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.