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Orange Book product · Generic (ANDA)

MECLIZINE HYDROCHLORIDE

MECLIZINE HYDROCHLORIDE

Generic (ANDA)ANDA 083784DISCN IVAX SUB TEVA PHARMS

At a glance

Approved Prior to Jan 1, 1982

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

No patent or exclusivity dates are listed for this product.

Pharmaceutical detail

Active ingredient

MECLIZINE HYDROCHLORIDE

Strength

12.5MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 083784

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.