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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Fish and Richardson
Queensland Health
Boehringer Ingelheim
Chubb
Dow
UBS
Fuji
Cerilliant

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204278

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NDA 204278 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 204278
Tradename:HYDROMORPHONE HYDROCHLORIDE
Applicant:Paddock Llc
Ingredient:hydromorphone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 204278
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 204278
Suppliers and Packaging for NDA: 204278
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204278 ANDA Paddock Laboratories, LLC 0574-0293 N 0574-0293-01
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204278 ANDA Paddock Laboratories, LLC 0574-0294 N 0574-0294-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength8MG
Approval Date:Apr 6, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength12MG
Approval Date:Apr 6, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength16MG
Approval Date:Apr 6, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
AstraZeneca
Dow
Mallinckrodt
Fish and Richardson
McKesson
Medtronic
US Department of Justice
Accenture

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