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Orange Book product · Generic (ANDA)

RALOXIFENE HYDROCHLORIDE

RALOXIFENE HYDROCHLORIDE

Generic (ANDA)ANDA 204310TE ABRX AUROBINDO PHARMA

At a glance

Aug 28, 2015

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 28, 2015

    11 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

RALOXIFENE HYDROCHLORIDE

Strength

60MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 204310

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of RALOXIFENE 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.