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Orange Book product · Generic (ANDA)

RALOXIFENE HYDROCHLORIDE

RALOXIFENE HYDROCHLORIDE

Generic (ANDA)ANDA 206384TE ABRX SCIEGEN PHARMS

At a glance

Oct 12, 2016

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 12, 2016

    9 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

RALOXIFENE HYDROCHLORIDE

Strength

60MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 206384

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.