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HYDROMORPHONE HYDROCHLORIDE

NDA · New Drug Application · Sponsor: HIKMA · Approved 2023-12-14

Drug application

FDA Application #

NDA217812

Application type

New Drug Application

Brand name

HYDROMORPHONE HYDROCHLORIDE

Generic name

HYDROMORPHONE HYDROCHLORIDE

Active ingredients

HYDROMORPHONE HYDROCHLORIDE

Dosage form

SOLUTION

Route

INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Marketing status

Prescription

Sponsor

HIKMA

Manufacturer

Hikma Pharmaceuticals USA Inc.

First approval

2023-12-14

Source

Authoritative

Drugs@FDA application overview

Machine

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