Assyro AI

Orange Book product · Generic (ANDA)

HAILEY FE 1.5/30

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Generic (ANDA)ANDA 209031TE ABRX GLENMARK SPECLT

At a glance

Jun 05, 2018

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 05, 2018

    8 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Strength

0.03MG;1.5MG

Dosage form

TABLET

Route

ORAL-28

TE code

AB

Application

ANDA 209031

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ETHINYL 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.