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Orange Book product · Generic (ANDA)

DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE

Generic (ANDA)ANDA 204778TE ATRX MICRO LABS

At a glance

Nov 08, 2019

Approved

Generic (ANDA)

Application

AT

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 08, 2019

    6 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DORZOLAMIDE HYDROCHLORIDE

Strength

EQ 2% BASE

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

AT

Application

ANDA 204778

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of DORZOLAMIDE HYDROCHLORIDE

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.