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Orange Book product · Generic (ANDA)

OLOPATADINE HYDROCHLORIDE

OLOPATADINE HYDROCHLORIDE

Generic (ANDA)ANDA 202853TE ABRX PADAGIS ISRAEL

At a glance

Jan 31, 2017

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 31, 2017

    9 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 202853

Product number

001

Marketing status

RX

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.