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Chinese Patent Office
Queensland Health
Daiichi Sankyo
Medtronic
Fuji
Dow
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Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076855

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NDA 076855 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 076855
Tradename:HYDROMORPHONE HYDROCHLORIDE
Applicant:Specgx Llc
Ingredient:hydromorphone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 076855
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 076855
Suppliers and Packaging for NDA: 076855
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 076855 ANDA SpecGx LLC 0406-3243 N 0406-3243-01
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 076855 ANDA SpecGx LLC 0406-3244 N 0406-3244-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:Dec 23, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Sep 19, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Sep 19, 2007TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
Julphar
Accenture
Daiichi Sankyo
AstraZeneca
Cantor Fitzgerald
Queensland Health
Medtronic

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