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Orange Book product · Generic (ANDA)

TIMOLOL MALEATE

TIMOLOL MALEATE

Generic (ANDA)ANDA 204936DISCN APOTEX

At a glance

Apr 17, 2015

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 17, 2015

    11 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TIMOLOL MALEATE

Strength

EQ 0.5% BASE

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

ANDA 204936

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of 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.