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Serving leading biopharmaceutical companies globally:

AstraZeneca
UBS
US Army
Deloitte
Farmers Insurance
US Department of Justice
Novartis
Cipla
Express Scripts
Chubb

Generated: January 20, 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, 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, Mallinckrodt, and Nesher Pharms, and is included in nineteen 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 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 076855
Tradename:HYDROMORPHONE HYDROCHLORIDE
Applicant:Mallinckrodt
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 0406-3243-01 100 TABLET in 1 BOTTLE (0406-3243-01)
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 076855 ANDA SpecGx LLC 0406-3244 0406-3244-01 100 TABLET in 1 BOTTLE (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 leading biopharmaceutical companies globally:

Harvard Business School
Moodys
Boehringer Ingelheim
Healthtrust
Citi
Covington
Cipla
Medtronic
Queensland Health

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