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Orange Book product · Generic (ANDA)

OLOPATADINE HYDROCHLORIDE

OLOPATADINE HYDROCHLORIDE

Generic (ANDA)ANDA 210901TE ABRX AMNEAL

At a glance

Jan 28, 2020

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 28, 2020

    6 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

OLOPATADINE HYDROCHLORIDE

Strength

0.665MG/SPRAY

Dosage form

SPRAY, METERED

Route

NASAL

TE code

AB

Application

ANDA 210901

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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.