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Orange Book product · Generic (ANDA)

ESTRADIOL AND NORETHINDRONE ACETATE

ESTRADIOL; NORETHINDRONE ACETATE

Generic (ANDA)ANDA 207261TE ABRX XIROMED

At a glance

Feb 10, 2017

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 10, 2017

    9 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ESTRADIOL; NORETHINDRONE ACETATE

Strength

0.5MG;0.1MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 207261

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ESTRADIOL; NORETHINDRONE ACETATE

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.