Assyro AI

Orange Book product · Generic (ANDA)

ASENAPINE MALEATE

ASENAPINE MALEATE

Generic (ANDA)ANDA 206098TE ABRX ALEMBIC

At a glance

Jul 19, 2021

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 19, 2021

    5 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

ASENAPINE MALEATE

Strength

EQ 2.5MG BASE

Dosage form

TABLET

Route

SUBLINGUAL

TE code

AB

Application

ANDA 206098

Product number

003

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ASENAPINE MALEATE

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.