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FDA NDA · NDA217812

HYDROMORPHONE HYDROCHLORIDE

Sponsor: HIKMA

APPLICATION
NDA217812
TYPE
NDA
ORIGINAL APPROVAL
2023-12-14
LATEST ACTION
2025-12-22
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

HYDROMORPHONE HYDROCHLORIDE · ReferencePrescription
HYDROMORPHONE HYDROCHLORIDE 40MG/20ML (2MG/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Approval history

2025-12-22Labeling · Supplement 1 · standard — Letter ↗AP
2023-12-14Type 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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