Assyro AI

Orange Book product · Generic (ANDA)

HALCINONIDE

HALCINONIDE

Generic (ANDA)ANDA 214723TE ABRX CHARTWELL RX

At a glance

Sep 08, 2021

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 08, 2021

    4 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HALCINONIDE

Strength

0.1%

Dosage form

CREAM

Route

TOPICAL

TE code

AB

Application

ANDA 214723

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of HALCINONIDE

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.