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Orange Book product · Generic (ANDA)

MECLIZINE HYDROCHLORIDE

MECLIZINE HYDROCHLORIDE

Generic (ANDA)ANDA 084843TE AARX SANDOZ
View MECLIZINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

May 22, 1989

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 22, 1989

    37 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

MECLIZINE HYDROCHLORIDE

Strength

12.5MG

Dosage form

TABLET

Route

ORAL

TE code

AA

Application

ANDA 084843

Product number

002

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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