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Orange Book product · Generic (ANDA)

LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOCETIRIZINE DIHYDROCHLORIDE

Generic (ANDA)ANDA 203646TE ABRX SCIEGEN PHARMS

At a glance

Sep 09, 2014

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 09, 2014

    11 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LEVOCETIRIZINE DIHYDROCHLORIDE

Strength

5MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 203646

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of LEVOCETIRIZINE DIHYDROCHLORIDE

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.