Assyro AI

Orange Book product · Generic (ANDA)

MIFEPRISTONE

MIFEPRISTONE

Generic (ANDA)ANDA 211436TE ABRX TEVA PHARMS USA INC

At a glance

Aug 03, 2020

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 03, 2020

    6 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

MIFEPRISTONE

Strength

300MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 211436

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of MIFEPRISTONE

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.