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Orange Book product · Generic (ANDA)

ETHINYL ESTRADIOL; ETONOGESTREL

ETHINYL ESTRADIOL; ETONOGESTREL

Generic (ANDA)ANDA 204305TE ABRX TEVA PHARMS USA INC

At a glance

Jan 13, 2021

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 13, 2021

    5 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ETHINYL ESTRADIOL; ETONOGESTREL

Strength

0.015MG/24HR;0.12MG/24HR

Dosage form

RING

Route

VAGINAL

TE code

AB

Application

ANDA 204305

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; ETONOGESTREL

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.