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Orange Book product · Generic (ANDA)

LEVONORGESTREL AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; LEVONORGESTREL

Generic (ANDA)ANDA 202791TE ABRX GLENMARK PHARMS LTD

At a glance

Apr 09, 2015

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 09, 2015

    11 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Strength

0.02MG;0.09MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 202791

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.