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Generated: December 17, 2017

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, 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-six suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

Summary for 078439

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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 35356-815-90 90 TABLET in 1 BOTTLE, PLASTIC (35356-815-90)
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 078439 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-815 35356-815-60 60 TABLET in 1 BOTTLE, PLASTIC (35356-815-60)

Summary for product number 001

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

Summary for product number 002

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


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