Assyro AI

Orange Book product · Generic (ANDA)

MECLIZINE HYDROCHLORIDE

MECLIZINE HYDROCHLORIDE

Generic (ANDA)ANDA 040179DISCN RISING

At a glance

Jan 30, 1997

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 30, 1997

    29 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

MECLIZINE HYDROCHLORIDE

Strength

12.5MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 040179

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.