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Orange Book product · Generic (ANDA)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY

FEXOFENADINE HYDROCHLORIDE

Generic (ANDA)ANDA 076502OTC DR REDDYS LABS LTD

At a glance

Apr 12, 2011

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 12, 2011

    15 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

FEXOFENADINE HYDROCHLORIDE

Strength

30MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 076502

Product number

004

Marketing status

OTC

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of FEXOFENADINE 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.