Assyro AI

Orange Book product · Generic (ANDA)

MECLIZINE HYDROCHLORIDE

MECLIZINE HYDROCHLORIDE

Generic (ANDA)ANDA 088733DISCN PLIVA

At a glance

Dec 11, 1985

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 11, 1985

    41 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

MECLIZINE HYDROCHLORIDE

Strength

25MG

Dosage form

TABLET, CHEWABLE

Route

ORAL

TE code

Not listed

Application

ANDA 088733

Product number

001

Marketing status

DISCN

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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.