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Orange Book product · Generic (ANDA)

BRIMONIDINE TARTRATE AND TIMOLOL MALEATE

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Generic (ANDA)ANDA 215598TE ABRX UPSHER SMITH LABS

At a glance

Dec 12, 2022

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 12, 2022

    3 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Strength

0.2%;EQ 0.5% BASE

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

AB

Application

ANDA 215598

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of BRIMONIDINE TARTRATE; TIMOLOL MALEATE

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.