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Last Updated: June 12, 2021

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Details for New Drug Application (NDA): 078591


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NDA 078591 describes HYDROMORPHONE HYDROCHLORIDE, which is a drug marketed by Akorn, Barr, Eurohlth Intl Sarl, Hospira, Hospira Inc, Watson Labs, Ascent Pharms Inc, Hikma, Lannett Co Inc, Actavis Labs Fl Inc, Osmotica, Paddock Labs Llc, Aurolife Pharma Llc, Nesher Pharms, Nostrum Labs Inc, and Specgx Llc, and is included in twenty-two 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. Seventeen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Summary for 078591
Tradename:HYDROMORPHONE HYDROCHLORIDE
Applicant:Hospira Inc
Ingredient:hydromorphone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078591
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 078591
Suppliers and Packaging for NDA: 078591
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride INJECTABLE;INJECTION 078591 ANDA Hospira, Inc. 0409-2634 0409-2634-01 10 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-01) > 1 mL in 1 VIAL, SINGLE-DOSE (0409-2634-10)
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride INJECTABLE;INJECTION 078591 ANDA Hospira, Inc. 0409-2634 0409-2634-05 10 VIAL, SINGLE-DOSE in 1 BOX (0409-2634-05) > 5 mL in 1 VIAL, SINGLE-DOSE (0409-2634-25)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Jun 17, 2008TE:APRLD:No

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