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Orange Book product · Generic (ANDA)

TIMOLOL MALEATE

TIMOLOL MALEATE

Generic (ANDA)ANDA 216653TE AT2RX SOMERSET THERAPS LLC

At a glance

Jul 03, 2024

Approved

Generic (ANDA)

Application

AT2

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 03, 2024

    2 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

TIMOLOL MALEATE

Strength

EQ 0.5% BASE

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

AT2

Application

ANDA 216653

Product number

001

Marketing status

RX

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.