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Orange Book product · Generic (ANDA)

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

Generic (ANDA)ANDA 078201DISCN RUBICON RESEARCH

At a glance

Oct 28, 2008

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 28, 2008

    17 yr 11 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 078201

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.