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Generated: June 26, 2017

DrugPatentWatch Database Preview

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, West-ward Pharms Int, Mallinckrodt, Paddock Llc, and Hospira, and is included in eighteen NDAs. It is available from nineteen 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. Twenty-seven suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

Summary for NDA: 078591

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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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Serving 500+ biopharmaceutical companies globally:

Covington
Teva
Moodys
Boehringer Ingelheim
Cantor Fitzgerald
Julphar
Chinese Patent Office
Cerilliant
Accenture
McKinsey

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