Assyro AI

Orange Book product · Generic (ANDA)

TERBUTALINE SULFATE

TERBUTALINE SULFATE

Generic (ANDA)ANDA 076770DISCN CHARTWELL INJECTABLE

At a glance

Apr 23, 2004

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 23, 2004

    22 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TERBUTALINE SULFATE

Strength

1MG/ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

ANDA 076770

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of TERBUTALINE 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.