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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 217812


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NDA 217812 describes HYDROMORPHONE HYDROCHLORIDE, which is a drug marketed by Barr, Hikma, Hospira, Hospira Inc, Rising, Watson Labs, Ascent Pharms Inc, Chartwell, Actavis Labs Fl Inc, Osmotica Pharm Us, Padagis Us, Aurolife Pharma Llc, Mpp Pharma, Nesher Pharms, and Specgx Llc, and is included in twenty-four NDAs. It is available from fourteen suppliers. Additional details are available on the HYDROMORPHONE HYDROCHLORIDE profile page.

The generic ingredient in HYDROMORPHONE HYDROCHLORIDE is hydromorphone hydrochloride. There are fourteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Summary for 217812
Tradename:HYDROMORPHONE HYDROCHLORIDE
Applicant:Hikma
Ingredient:hydromorphone hydrochloride
Patents:0
Pharmacology for NDA: 217812
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 217812
Analgesics, Opioid
Narcotics
Suppliers and Packaging for NDA: 217812
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS 217812 NDA Hikma Pharmaceuticals USA Inc. 0641-6254 0641-6254-01 1 VIAL in 1 CARTON (0641-6254-01) / 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSStrength40MG/20ML (2MG/ML)
Approval Date:Dec 14, 2023TE:RLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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