Assyro AI

Orange Book product · Generic (ANDA)

ALBUTEROL SULFATE

ALBUTEROL SULFATE

Generic (ANDA)ANDA 079241TE AARX AMNEAL PHARMS

At a glance

May 12, 2010

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 12, 2010

    16 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ALBUTEROL SULFATE

Strength

EQ 2MG BASE/5ML

Dosage form

SYRUP

Route

ORAL

TE code

AA

Application

ANDA 079241

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.