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Orange Book product · Generic (ANDA)

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

Generic (ANDA)ANDA 091180DISCN ZAMBON SPA

At a glance

Dec 04, 2013

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 04, 2013

    12 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

Strength

EQ 2% BASE;EQ 0.5% BASE

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

ANDA 091180

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of DORZOLAMIDE HYDROCHLORIDE; 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.