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Orange Book product · Generic (ANDA)

NEBIVOLOL HYDROCHLORIDE

NEBIVOLOL HYDROCHLORIDE

Generic (ANDA)ANDA 203741DISCN ALKEM LABS LTD

At a glance

Jun 24, 2015

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 24, 2015

    11 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NEBIVOLOL HYDROCHLORIDE

Strength

EQ 2.5MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 203741

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of NEBIVOLOL 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.