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Orange Book product · Generic (ANDA)

LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOCETIRIZINE DIHYDROCHLORIDE

Generic (ANDA)ANDA 204599TE AARX CHARTWELL MOLECULAR

At a glance

May 15, 2017

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 15, 2017

    9 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

LEVOCETIRIZINE DIHYDROCHLORIDE

Strength

2.5MG/5ML

Dosage form

SOLUTION

Route

ORAL

TE code

AA

Application

ANDA 204599

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.