Assyro AI

Orange Book product · Brand (NDA)

APOKYN

APOMORPHINE HYDROCHLORIDE

Brand (NDA)NDA 021264TE APRX MDD US
View APOMORPHINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Apr 20, 2004

Approved

Brand (NDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 20, 2004

    22 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

APOMORPHINE HYDROCHLORIDE

Strength

30MG/3ML (10MG/ML)

Dosage form

INJECTABLE

Route

SUBCUTANEOUS

TE code

AP

Application

NDA 021264

Product number

002

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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.

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