Assyro AI

Orange Book product · Generic (ANDA)

FALMINA

ETHINYL ESTRADIOL; LEVONORGESTREL

Generic (ANDA)ANDA 090721TE AB1RX NOVAST LABS LTD

At a glance

Mar 28, 2012

Approved

Generic (ANDA)

Application

AB1

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 28, 2012

    14 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Strength

0.02MG;0.1MG

Dosage form

TABLET

Route

ORAL-28

TE code

AB1

Application

ANDA 090721

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; 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.