Assyro AI

Orange Book product · Generic (ANDA)

APOMORPHINE HYDROCHLORIDE

APOMORPHINE HYDROCHLORIDE

Generic (ANDA)ANDA 212025TE APRX TP ANDA HOLDINGS

At a glance

Feb 23, 2022

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 23, 2022

    4 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

APOMORPHINE HYDROCHLORIDE

Strength

30MG/3ML (10MG/ML)

Dosage form

INJECTABLE

Route

SUBCUTANEOUS

TE code

AP

Application

ANDA 212025

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of APOMORPHINE HYDROCHLORIDE

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.