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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 Hospira Inc, Nesher Pharms, Aurolife Pharma Llc, Watson Labs, Elite Labs, Akorn, Osmotica, Lannett, Barr, Actavis Labs Fl Inc, Roxane, Mallinckrodt, Paddock Llc, and Hospira, and is included in eighteen NDAs. It is available from twenty suppliers. Additional details are available on the HYDROMORPHONE HYDROCHLORIDE profile page.

The generic ingredient in HYDROMORPHONE HYDROCHLORIDE is hydromorphone hydrochloride. There are thirteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

Summary for NDA: 078591

Tradename:
HYDROMORPHONE HYDROCHLORIDE
Applicant:
Hospira Inc
Ingredient:
hydromorphone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 078591

Mechanism of ActionFull Opioid Agonists

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
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

Summary for product number 001

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


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