Assyro AI

Orange Book product · Generic (ANDA)

ELIFEMME

ETHINYL ESTRADIOL; LEVONORGESTREL

Generic (ANDA)ANDA 202507DISCN XIROMED

At a glance

Dec 04, 2015

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 04, 2015

    10 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Strength

0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG

Dosage form

TABLET

Route

ORAL-28

TE code

Not listed

Application

ANDA 202507

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ETHINYL ESTRADIOL; LEVONORGESTREL

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.