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FDA NDA · NDA214056

ONAPGO

apomorphine hydrochloride

Sponsor: MDD US

APPLICATION
NDA214056
TYPE
NDA
ORIGINAL APPROVAL
2025-02-03
LATEST ACTION
2026-06-30
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ONAPGO · ReferencePrescription
APOMORPHINE HYDROCHLORIDE 98MG/20ML (4.9MG/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2026-06-30Labeling · Supplement 6 · standard — Letter ↗AP
2026-05-15Labeling · Supplement 5 · standard — Letter ↗AP
2025-02-03Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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