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Orange Book product · Generic (ANDA)

OLOPATADINE HYDROCHLORIDE

OLOPATADINE HYDROCHLORIDE

Generic (ANDA)ANDA 078350OTC APOTEX

At a glance

Dec 07, 2015

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 07, 2015

    10 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

OLOPATADINE HYDROCHLORIDE

Strength

EQ 0.1% BASE

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

ANDA 078350

Product number

001

Marketing status

OTC

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of OLOPATADINE 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.