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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077471

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NDA 077471 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 077471
Tradename:HYDROMORPHONE HYDROCHLORIDE
Applicant:Lannett Co Inc
Ingredient:hydromorphone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 077471
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 077471
Suppliers and Packaging for NDA: 077471
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 077471 ANDA Lannett Company, Inc. 0527-1353 N 0527-1353-01
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 077471 ANDA Lannett Company, Inc. 0527-1354 N 0527-1354-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength8MG
Approval Date:Dec 9, 2009TE:ABRLD:No

Profile for product number 002

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

Profile for product number 003

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

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