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Orange Book product · Generic (ANDA)

MECLIZINE HYDROCHLORIDE

MECLIZINE HYDROCHLORIDE

Generic (ANDA)ANDA 200294TE AARX EPIC PHARMA LLC
View MECLIZINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Apr 13, 2012

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 13, 2012

    14 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

MECLIZINE HYDROCHLORIDE

Strength

12.5MG

Dosage form

TABLET

Route

ORAL

TE code

AA

Application

ANDA 200294

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of MECLIZINE 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.

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