Assyro AI

Orange Book product · Generic (ANDA)

ONSURA

ETHINYL ESTRADIOL; NORELGESTROMIN

Generic (ANDA)ANDA 213977TE ABRX TEVA PHARMS USA

At a glance

Aug 25, 2021

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 25, 2021

    4 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ETHINYL ESTRADIOL; NORELGESTROMIN

Strength

0.035MG/24HR;0.15MG/24HR

Dosage form

FILM, EXTENDED RELEASE

Route

TRANSDERMAL

TE code

AB

Application

ANDA 213977

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; NORELGESTROMIN

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.