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FDA NDA · NDA021264

APOKYN

Sponsor: MDD US

APPLICATION
NDA021264
TYPE
NDA
ORIGINAL APPROVAL
2004-04-20
LATEST ACTION
2025-02-03
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

APOKYNDiscontinued
APOMORPHINE HYDROCHLORIDE 20MG/2ML (10MG/ML) · INJECTABLE · SUBCUTANEOUS
APOKYN · ReferencePrescription
APOMORPHINE HYDROCHLORIDE 30MG/3ML (10MG/ML) · INJECTABLE · SUBCUTANEOUS

Approval history

2025-02-03Manufacturing (CMC) · Supplement 25 · standard — Label ↗AP
2022-06-22Labeling · Supplement 21 · standard — Letter ↗AP
2022-05-05Labeling · Supplement 22 · standard — Letter ↗AP
2020-05-01Labeling · Supplement 18 · standard — Label ↗AP
2019-12-03Labeling · Supplement 17 · standard — Letter ↗AP
2019-05-20Labeling · Supplement 16 · standard — Label ↗AP
2017-03-16Efficacy · Supplement 14 · standard — Label ↗AP
2014-07-25Labeling · Supplement 10 · standard — Letter ↗AP
2010-09-02Labeling · Supplement 9 · standard — Letter ↗AP
2008-12-31Labeling · Supplement 3 · standard — Letter ↗AP
2008-12-31Labeling · Supplement 5 · standard — Letter ↗AP
2004-04-20Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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