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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Express Scripts
Harvard Business School

Generated: March 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078439

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NDA 078439 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, 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 078439
Ingredient:hydromorphone hydrochloride
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 078439
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 078439
Suppliers and Packaging for NDA: 078439
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 078439 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-815 N 35356-815-60
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 078439 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-815 N 35356-815-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Dec 9, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Dec 9, 2009TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Daiichi Sankyo

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