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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Dow
Farmers Insurance
Colorcon
Healthtrust
Merck
US Army
Boehringer Ingelheim
Citi

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076723

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NDA 076723 describes HYDROMORPHONE HYDROCHLORIDE, which is a drug marketed by Akorn, Barr, Eurohlth Intl Sarl, Hospira, Hospira Inc, Watson Labs, Ascent Pharms Inc, West-ward Pharms Int, Actavis Labs Fl Inc, Osmotica, Paddock Llc, Aurolife Pharma Llc, Elite Labs, Lannett Co Inc, Nesher Pharms, and Specgx Llc, and is included in twenty NDAs. It is available from twenty-one 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-five suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.
Summary for 076723
Tradename:HYDROMORPHONE HYDROCHLORIDE
Applicant:Elite Labs
Ingredient:hydromorphone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 076723
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 076723
Suppliers and Packaging for NDA: 076723
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 076723 ANDA TAGI Pharma, Inc. 51224-102 N 51224-102-50
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 076723 ANDA Precision Dose Inc. 68094-852 N 68094-852-61

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:Oct 18, 2005TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
US Department of Justice
Fish and Richardson
Queensland Health
Deloitte
Colorcon
QuintilesIMS
Federal Trade Commission
Baxter

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